Клинические исследование Renal Insufficiency, Chronic: Sodium Zirconium Cyclosilicate (SZC), Placebo, Lisinopril, Valsartan, Irbesartan

Спонсоры	Ведущий спонсор: AstraZeneca
Источник	AstraZeneca
Краткое содержание	The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate [eGFR] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.

Подробное описание

This is a Phase 3, international, randomised withdrawal, double-blind, parallel-group, placebo-controlled study, to evaluate the effect of SZC as adjunct to RAASi therapy (lisinopril or valsartan) in slowing CKD progression in participants with CKD and hyperkalaemia or at risk of hyperkalaemia. Specifically, the study will include participants with hyperkalaemia (S-K > 5.0 to ≤ 6.5 mmol/L by central laboratory) who are on adequate or limited RAASi therapy due to hyperkalaemia, and participants with normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L by central laboratory) who are on limited RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as (1) participants with a previous medical history or record of hyperkalaemia within the prior 24 months who are on limited RAASi therapy despite indication in CKD; (2) participants in whom RAASi therapy is indicated in CKD but are on limited RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L; and (3) participants in whom RAASi therapy has been discontinued or reduced to suboptimal doses because of hyperkalaemia. A participant is expected to be in the study for approximately 28 months, which includes up to 13 days for the screening period, 27 months for the intervention period, and 1 week for follow-up. The 27-month intervention period of the study consists of 3 phases, an initiation phase (up to 72 hours), a run-in phase (3 months/up to Day 90), and a maintenance phase (24 months/104 weeks). The initial dose of SZC will be administered to participants during the initiation phase. No changes will be made to the ACEi or ARB therapy at this stage. As soon as possible after the participant is confirmed to be normokalaemic at the end of the initiation phase, the participant will enter the run-in phase. Participants will receive open-label SZC and either lisinopril or valsartan. The aim of the run-in phase is to increase ACEi or ARB therapy stepwise to their maximum doses. After a 3-month run-in period for RAASi dose optimization while on SZC, participants will be randomized to SZC or placebo and followed during the subsequent 24 months of maintenance phase for efficacy and safety assessments.

Общий статус

Recruiting

Дата начала

2021-09-30

Дата завершения

2025-01-15

Дата первичного завершения

2025-01-15

Фаза

Phase 3

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Total eGFR slope and Chronic eGFR slope	Total slope: from randomisation visit to the end of the maintenance phase at Week 104; Chronic slope: from Week 12 visit to the end of the maintenance phase at Week 104

Вторичный результат

Мера	Временное ограничение
Time from randomisation to the first occurrence of any component in the composite of: Sustained ≥ 40% decline in eGFR; Onset of ESKD (kidney transplantation, maintenance dialysis, or sustained low eGFR); Death from kidney failure	From randomisation visit to the end of the maintenance phase at Week 104
Time from randomisation to first lisinopril/valsartan dose decrease	From randomisation visit to the end of the maintenance phase at Week 104
UACR measurements	From randomisation visit to the end of the maintenance phase at Week 104
Serum bicarbonate measurements	From randomisation visit to the end of the maintenance phase at Week 104
S-K level classification	From randomisation visit to the end of the maintenance phase at Week 104

Регистрация

1500

Состояние	Renal Insufficiency, Chronic Hyperkalemia
Вмешательство	Тип вмешательства: Drug Название вмешательства: Sodium Zirconium Cyclosilicate (SZC) Описание: Powder for oral suspension in a sachet. Unit dose strength: 5 or 10 g SZC. Single dose will consist of 1-3 sachets. During Initiation Phase: S-K > 5 to ≤ 6.5 mmol/L (measured by L-Lab): Single dose contains 10 g SZC that should be suspended in 45 mL of water and administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L) S-K ≥ 3.5 to ≤ 5 mmol/L (measured by L-Lab): Single dose contains 5 g SZC that should be suspended in 45 mL of water and administered once daily for 48 hours. During Run-in and Maintenance Phases: - Single dose contains 5 g SZC administered every other day or 5, 10, or 15 g SZC administered once daily that should be suspended in 45 mL of water. Этикетка Arm Group: Sodium Zirconium Cyclosilicate (SZC) Другое имя: Lokelma TM Тип вмешательства: Drug Название вмешательства: Placebo Описание: Powder for oral suspension in a sachet. Placebo to match 5 or 10 g. Single dose will consist of 1-3 sachets. During Maintenance Phase: - Single dose contains 5 g placebo administered every other day or 5, 10, or 15 g placebo administered once daily that should be suspended in 45 mL of water. Этикетка Arm Group: Placebo Тип вмешательства: Drug Название вмешательства: Lisinopril Описание: Tablet for oral administration. Unit dose strength: 5 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily. Тип вмешательства: Drug Название вмешательства: Valsartan Описание: Tablet or capsule for oral administration. Unit dose strength: 40 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily. Тип вмешательства: Drug Название вмешательства: Irbesartan Описание: Tablet for oral administration. Unit dose strength: 75, 150 or 300 mg. Dosage level: 75, 150, or 300 mg administered once daily. The study is designed to use valsartan as the selected ARB therapy adjunct to SZC. However, if an actual shortage of valsartan in a local market jeopardises the ability of participants to enter or continue in the study, valsartan can be temporarily substituted with irbesartan until the shortage of valsartan is resolved.
Приемлемость	Критерии: Inclusion Criteria: - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol - Must be ≥ 18 years of age at the time of signing the informed consent. For participants < 20 years of age and enrolled in Japan, a written informed consent should be obtained from the participant and his or her legally acceptable representative - Must have eGFR ≥ 25 and ≤ 59 mL/min/1.73m2 as calculated by central laboratory (CKD-EPI formula) at screening (Visit 1) - Must have UACR ≥ 200 and ≤ 5000 mg/g as calculated by central laboratory at screening (Visit 1) - Any of the following criteria, a or b, at screening (Visit 1): 1. Cohort A: Hyperkalaemia (S-K > 5.0 to ≤ 6.5 mmol/L) as measured by the central laboratory, and on adequate* or limited RAASi therapy due to hyperkalaemia. 2. Cohort B: Normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L) as measured by the central laboratory and on limited RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as: (i) Participants with a previous medical history or record of hyperkalaemia within the prior 24 months, who are on limited RAASi therapy despite indication in CKD. (ii) Participants in whom RAASi therapy is indicated in CKD, who are on limited RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L. (iii) Participants in whom RAASi therapy has been discontinued or reduced to suboptimal* doses because of hyperkalaemia. Adequate RAASi dose levels are defined in protocol; doses lower than these are considered as suboptimal. *Limited RAASi therapy is defined as no or suboptimal RAASi therapy according to dosing guidance provided in protocol. - If on thiazide or loop diuretics, the dose must have been stable for 2 weeks prior to screening (Visit 1). - If on RAASi therapy, the dose must have been stable for one month prior to screening (Visit 1) and remain stable during screening. - If on an SGLT2i treatment, the dose must have been stable for 3 months prior to screening (Visit 1). - Participants must be one-year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of one month prior to screening (Visit 1) and willing to remain on the birth control until one month after the last dose of study intervention. Exclusion Criteria: - New York Heart Association class III to IV congestive heart failure at the time of screening (Visit 1) or previous history of severe or symptomatic heart failure. - Myocardial infarction, unstable angina, stroke, or transient ischaemic attack within 3 months prior to screening (Visit 1). - Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg (confirmed by repeated measurement), within 2 weeks prior to screening (Visit 1). Participants may be rescreened once blood pressure is controlled. - QTcF > 550 msec at screening (Visit 1). - History of QT prolongation associated with other medications that required discontinuation of that medication. - Congenital long QT syndrome. - Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation and heart rate controlled by medication are permitted. - Type 1 diabetes mellitus. - Lupus nephritis or anti neutrophil cytoplasmic antibody-associated vasculitis. - Change in renal function requiring hospitalisation or dialysis within 3 months prior to screening (Visit 1). - History of renal transplant (or anticipated need for renal transplant during the study). - Severe hepatic impairment, biliary cirrhosis, or cholestasis. - History of hereditary or idiopathic angioedema. - Any prior hypersensitivity to ACEi or ARB that in the investigator's judgment precludes use of lisinopril and valsartan/irbesartan. Prior hypersensitivity reactions to consider include, but are not limited to, development of angioedema, icterus, hepatitis, or neutropaenia or thrombocytopaenia requiring treatment modification. - Known hypersensitivity or previous anaphylaxis to SZC or to components thereof. - Any condition outside the CV and renal disease area such as, but not limited to, malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgment. - Active malignancy requiring treatment at the time of screening (Visit 1), except for successfully treated basal cell or treated squamous cell carcinoma. - S-K > 6.5 or < 3.5 mmol/L by local laboratory within 1 day prior to the scheduled first dose of SZC in the initiation phase. - Evidence of COVID-19 infection within 2 weeks prior to screening (Visit 1). - Treated with dual blockade of RAAS (combined use of an ACEi and ARB) within 3 months prior to screening (Visit 1). - Treated with an angiotensin receptor neprilysin inhibitor (ARNI; sacubitril/valsartan [Entresto®]) within 3 months prior to screening (Visit 1). - Treated with an MRA within 3 months prior to screening (Visit 1). - Treated with aliskiren-containing products with 3 months prior to screening (Visit 1). - Treated with SPS (eg, Kayexalate, Resonium), CPS (Resonium Calcium), patiromer (Veltassa®), or SZC (Lokelma®) within 7 days prior to screening (Visit 1). - Participation in another clinical study with an investigational product administered within one month prior to screening (Visit 1). - Not willing or not able to change to lisinopril or valsartan/irbesartan, the protocol-mandated RAASi study intervention. - Previous dosing with SZC in the present study. - Currently pregnant (confirmed with positive pregnancy test at screening [Visit 1]) or breastfeeding. - Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements. - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Пол: All Минимальный возраст: 18 Years Максимальный возраст: 130 Years Здоровые волонтеры: No

Состояние

Renal Insufficiency, Chronic
Hyperkalemia

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Sodium Zirconium Cyclosilicate (SZC)

Описание: Powder for oral suspension in a sachet. Unit dose strength: 5 or 10 g SZC. Single dose will consist of 1-3 sachets. During Initiation Phase: S-K > 5 to ≤ 6.5 mmol/L (measured by L-Lab): Single dose contains 10 g SZC that should be suspended in 45 mL of water and administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L) S-K ≥ 3.5 to ≤ 5 mmol/L (measured by L-Lab): Single dose contains 5 g SZC that should be suspended in 45 mL of water and administered once daily for 48 hours. During Run-in and Maintenance Phases: - Single dose contains 5 g SZC administered every other day or 5, 10, or 15 g SZC administered once daily that should be suspended in 45 mL of water.

Этикетка Arm Group: Sodium Zirconium Cyclosilicate (SZC)

Другое имя: Lokelma TM

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Powder for oral suspension in a sachet. Placebo to match 5 or 10 g. Single dose will consist of 1-3 sachets. During Maintenance Phase: - Single dose contains 5 g placebo administered every other day or 5, 10, or 15 g placebo administered once daily that should be suspended in 45 mL of water.

Этикетка Arm Group: Placebo

Тип вмешательства: Drug

Название вмешательства: Lisinopril

Описание: Tablet for oral administration. Unit dose strength: 5 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily.

Тип вмешательства: Drug

Название вмешательства: Valsartan

Описание: Tablet or capsule for oral administration. Unit dose strength: 40 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily.

Тип вмешательства: Drug

Название вмешательства: Irbesartan

Описание: Tablet for oral administration. Unit dose strength: 75, 150 or 300 mg. Dosage level: 75, 150, or 300 mg administered once daily. The study is designed to use valsartan as the selected ARB therapy adjunct to SZC. However, if an actual shortage of valsartan in a local market jeopardises the ability of participants to enter or continue in the study, valsartan can be temporarily substituted with irbesartan until the shortage of valsartan is resolved.

Приемлемость

Критерии:

Inclusion Criteria: - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and protocol - Must be ≥ 18 years of age at the time of signing the informed consent. For participants < 20 years of age and enrolled in Japan, a written informed consent should be obtained from the participant and his or her legally acceptable representative - Must have eGFR ≥ 25 and ≤ 59 mL/min/1.73m2 as calculated by central laboratory (CKD-EPI formula) at screening (Visit 1) - Must have UACR ≥ 200 and ≤ 5000 mg/g as calculated by central laboratory at screening (Visit 1) - Any of the following criteria, a or b, at screening (Visit 1): 1. Cohort A: Hyperkalaemia (S-K > 5.0 to ≤ 6.5 mmol/L) as measured by the central laboratory, and on adequate* or limited** RAASi therapy due to hyperkalaemia. 2. Cohort B: Normokalaemia (S-K ≥ 3.5 to ≤ 5.0 mmol/L) as measured by the central laboratory and on limited** RAASi therapy due to high risk of hyperkalaemia. High risk of hyperkalaemia is defined as: (i) Participants with a previous medical history or record of hyperkalaemia within the prior 24 months, who are on limited** RAASi therapy despite indication in CKD. (ii) Participants in whom RAASi therapy is indicated in CKD, who are on limited** RAASi therapy and have S-K ≥ 4.7 to ≤ 5.0 mmol/L. (iii) Participants in whom RAASi therapy has been discontinued or reduced to suboptimal* doses because of hyperkalaemia. *Adequate RAASi dose levels are defined in protocol; doses lower than these are considered as suboptimal. **Limited RAASi therapy is defined as no or suboptimal RAASi therapy according to dosing guidance provided in protocol. - If on thiazide or loop diuretics, the dose must have been stable for 2 weeks prior to screening (Visit 1). - If on RAASi therapy, the dose must have been stable for one month prior to screening (Visit 1) and remain stable during screening. - If on an SGLT2i treatment, the dose must have been stable for 3 months prior to screening (Visit 1). - Participants must be one-year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of one month prior to screening (Visit 1) and willing to remain on the birth control until one month after the last dose of study intervention. Exclusion Criteria: - New York Heart Association class III to IV congestive heart failure at the time of screening (Visit 1) or previous history of severe or symptomatic heart failure. - Myocardial infarction, unstable angina, stroke, or transient ischaemic attack within 3 months prior to screening (Visit 1). - Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg (confirmed by repeated measurement), within 2 weeks prior to screening (Visit 1). Participants may be rescreened once blood pressure is controlled. - QTcF > 550 msec at screening (Visit 1). - History of QT prolongation associated with other medications that required discontinuation of that medication. - Congenital long QT syndrome. - Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation and heart rate controlled by medication are permitted. - Type 1 diabetes mellitus. - Lupus nephritis or anti neutrophil cytoplasmic antibody-associated vasculitis. - Change in renal function requiring hospitalisation or dialysis within 3 months prior to screening (Visit 1). - History of renal transplant (or anticipated need for renal transplant during the study). - Severe hepatic impairment, biliary cirrhosis, or cholestasis. - History of hereditary or idiopathic angioedema. - Any prior hypersensitivity to ACEi or ARB that in the investigator's judgment precludes use of lisinopril and valsartan/irbesartan. Prior hypersensitivity reactions to consider include, but are not limited to, development of angioedema, icterus, hepatitis, or neutropaenia or thrombocytopaenia requiring treatment modification. - Known hypersensitivity or previous anaphylaxis to SZC or to components thereof. - Any condition outside the CV and renal disease area such as, but not limited to, malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgment. - Active malignancy requiring treatment at the time of screening (Visit 1), except for successfully treated basal cell or treated squamous cell carcinoma. - S-K > 6.5 or < 3.5 mmol/L by local laboratory within 1 day prior to the scheduled first dose of SZC in the initiation phase. - Evidence of COVID-19 infection within 2 weeks prior to screening (Visit 1). - Treated with dual blockade of RAAS (combined use of an ACEi and ARB) within 3 months prior to screening (Visit 1). - Treated with an angiotensin receptor neprilysin inhibitor (ARNI; sacubitril/valsartan [Entresto®]) within 3 months prior to screening (Visit 1). - Treated with an MRA within 3 months prior to screening (Visit 1). - Treated with aliskiren-containing products with 3 months prior to screening (Visit 1). - Treated with SPS (eg, Kayexalate, Resonium), CPS (Resonium Calcium), patiromer (Veltassa®), or SZC (Lokelma®) within 7 days prior to screening (Visit 1). - Participation in another clinical study with an investigational product administered within one month prior to screening (Visit 1). - Not willing or not able to change to lisinopril or valsartan/irbesartan, the protocol-mandated RAASi study intervention. - Previous dosing with SZC in the present study. - Currently pregnant (confirmed with positive pregnancy test at screening [Visit 1]) or breastfeeding. - Judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements. - Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

130 Years

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
Glenn M. Chertow, MD, MPH	Principal Investigator	Stanford University School of Medicine, Stanford, CA USA

Общий контакт

Фамилия: AstraZeneca Clinical Study Information Center

Телефон: 1-877-240-9479

Расположение

Объект:	Положение дел:
Research Site \| Tucson, Arizona, 85741, United States	Not yet recruiting
Research Site \| Canyon Country, California, 91351, United States	Recruiting
Research Site \| Granada Hills, California, 91344, United States	Not yet recruiting
Research Site \| Granada Hills, California, 91344, United States	Withdrawn
Research Site \| Northridge, California, 91324, United States	Recruiting
Research Site \| Palo Alto, California, 94304, United States	Withdrawn
Research Site \| Palo Alto, California, 94304, United States	Not yet recruiting
Research Site \| S. Gate, California, 90280, United States	Not yet recruiting
Research Site \| San Dimas, California, 91773, United States	Recruiting
Research Site \| Tarzana, California, 91356, United States	Not yet recruiting
Research Site \| Boynton Beach, Florida, 33435, United States	Recruiting
Research Site \| Hialeah, Florida, 33012, United States	Recruiting
Research Site \| Lauderdale Lakes, Florida, 33313, United States	Recruiting
Research Site \| Miami, Florida, 33126, United States	Recruiting
Research Site \| Ocoee, Florida, 34761, United States	Recruiting
Research Site \| Temple Terrace, Florida, 33637, United States	Not yet recruiting
Research Site \| Nampa, Idaho, 83687, United States	Not yet recruiting
Research Site \| Chicago, Illinois, 60643, United States	Not yet recruiting
Research Site \| Hinsdale, Illinois, 60521, United States	Not yet recruiting
Research Site \| Flint, Michigan, 48532, United States	Recruiting
Research Site \| Saint Clair Shores, Michigan, 48081, United States	Not yet recruiting
Research Site \| Columbia, Missouri, 65201, United States	Not yet recruiting
Research Site \| Kansas City, Missouri, 64111, United States	Recruiting
Research Site \| Great Neck, New York, 11021, United States	Not yet recruiting
Research Site \| New Bern, North Carolina, 28562, United States	Not yet recruiting
Research Site \| New Bern, North Carolina, 28562, United States	Withdrawn
Research Site \| Winston-Salem, North Carolina, 27103, United States	Recruiting
Research Site \| Cincinnati, Ohio, 45267, United States	Not yet recruiting
Research Site \| Bethlehem, Pennsylvania, 18017, United States	Not yet recruiting
Research Site \| Chester, Pennsylvania, 19013, United States	Recruiting
Research Site \| Arlington, Texas, 76015, United States	Not yet recruiting
Research Site \| Arlington, Texas, 76015, United States	Recruiting
Research Site \| Fort Worth, Texas, 76164, United States	Recruiting
Research Site \| Houston, Texas, 77099, United States	Recruiting
Research Site \| San Antonio, Texas, 78212, United States	Recruiting
Research Site \| Newport News, Virginia, 23606, United States	Recruiting
Research Site \| Milwaukee, Wisconsin, 53226, United States	Not yet recruiting
Research Site \| Buenos Aires, ARG 1425, Argentina	Not yet recruiting
Research Site \| Buenos Aires, B7600FYW, Argentina	Not yet recruiting
Research Site \| Buenos Aires, C1429BWN, Argentina	Not yet recruiting
Research Site \| Caba, C1120AAC, Argentina	Not yet recruiting
Research Site \| Caba, C1440AAD, Argentina	Not yet recruiting
Research Site \| La Plata, 1900, Argentina	Not yet recruiting
Research Site \| Mar del Plata, 7600, Argentina	Not yet recruiting
Research Site \| Sarandi, B1872EEC, Argentina	Not yet recruiting
Research Site \| Blagoevgrad, 2700, Bulgaria	Not yet recruiting
Research Site \| Dupnitsa, 2600, Bulgaria	Not yet recruiting
Research Site \| Gotse Delchev, 2900, Bulgaria	Recruiting
Research Site \| Kozloduy, 3320, Bulgaria	Recruiting
Research Site \| Kozloduy, 3320, Bulgaria	Not yet recruiting
Research Site \| Pazardzhik, 4400, Bulgaria	Not yet recruiting
Research Site \| Plovdiv, 4004, Bulgaria	Recruiting
Research Site \| Samokov, 2000, Bulgaria	Not yet recruiting
Research Site \| Sandanski, 2800, Bulgaria	Recruiting
Research Site \| Silistra, 7500, Bulgaria	Not yet recruiting
Research Site \| Smolyan, 3700, Bulgaria	Not yet recruiting
Research Site \| Baotou, 014010, China	Not yet recruiting
Research Site \| Beijing, 100029, China	Not yet recruiting
Research Site \| Beijing, 100034, China	Not yet recruiting
Research Site \| Beijing, 100044, China	Not yet recruiting
Research Site \| Beijing, 100050, China	Withdrawn
Research Site \| Beijing, 100191, China	Not yet recruiting
Research Site \| Beijing, 100730, China	Not yet recruiting
Research Site \| Beijing, 102206, China	Not yet recruiting
Research Site \| Beijing, 102218, China	Not yet recruiting
Research Site \| Changchun, 130041, China	Not yet recruiting
Research Site \| Changsha, 410008, China	Withdrawn
Research Site \| Changsha, 410013, China	Not yet recruiting
Research Site \| Changsha, 430033, China	Not yet recruiting
Research Site \| Chengdu, 610041, China	Not yet recruiting
Research Site \| Chongqing, 400010, China	Not yet recruiting
Research Site \| Guangzhou, 510630, China	Not yet recruiting
Research Site \| Guiyang, 550002, China	Not yet recruiting
Research Site \| Hangzhou, 310014, China	Not yet recruiting
Research Site \| Hefei, 230022, China	Withdrawn
Research Site \| Hefei, 230601, China	Not yet recruiting
Research Site \| Hengyang, 421001, China	Not yet recruiting
Research Site \| Huizhou, 516001, China	Not yet recruiting
Research Site \| Lanzhou, 730000, China	Withdrawn
Research Site \| Lanzhou, 730030, China	Not yet recruiting
Research Site \| Nanchang, 330006, China	Withdrawn
Research Site \| Nanchang, 330006, China	Not yet recruiting
Research Site \| Nanjing, 210009, China	Not yet recruiting
Research Site \| Nanjing, 210011, China	Not yet recruiting
Research Site \| Nanjing, 210029, China	Not yet recruiting
Research Site \| Ningbo, 315010, China	Not yet recruiting
Research Site \| Sanya, 572000, China	Not yet recruiting
Research Site \| Shanghai, 200025, China	Not yet recruiting
Research Site \| Shanghai, 200040, China	Not yet recruiting
Research Site \| Shanghai, 201199, China	Not yet recruiting
Research Site \| Shanghai, 201210, China	Not yet recruiting
Research Site \| Shantou, 515041, China	Not yet recruiting
Research Site \| Shengyang, 110004, China	Not yet recruiting
Research Site \| Shenyang, 110001, China	Not yet recruiting
Research Site \| Shenzhen, 518036, China	Not yet recruiting
Research Site \| Taiyuan, 030012, China	Not yet recruiting
Research Site \| Urumqi, 830054, China	Not yet recruiting
Research Site \| Wenzhou, 325027, China	Withdrawn
Research Site \| Wuhan, 430010, China	Not yet recruiting
Research Site \| Wuhan, 430060, China	Not yet recruiting
Research Site \| Wuxi, 214023, China	Not yet recruiting
Research Site \| Xi'an, 710032, China	Withdrawn
Research Site \| Xi'an, 710061, China	Not yet recruiting
Research Site \| Xinxiang, 453100, China	Not yet recruiting
Research Site \| Xuzhou, 221000, China	Not yet recruiting
Research Site \| Yantai, 264000, China	Not yet recruiting
Research Site \| Yinchuan, 750004, China	Not yet recruiting
Research Site \| Zhanjiang, 524001, China	Withdrawn
Research Site \| Zhengzhou, China	Not yet recruiting
Research Site \| Zhuzhou, 412007, China	Not yet recruiting
Research Site \| Bari, 70124, Italy	Not yet recruiting
Research Site \| Brescia, 25123, Italy	Not yet recruiting
Research Site \| Messina, 98125, Italy	Not yet recruiting
Research Site \| Parma, Italy	Not yet recruiting
Research Site \| Pavia, 27100, Italy	Recruiting
Research Site \| Piacenza, 29100, Italy	Withdrawn
Research Site \| Roma, 00161, Italy	Not yet recruiting
Research Site \| Roma, 00168, Italy	Not yet recruiting
Research Site \| San Giovanni Rotondo, 71013, Italy	Recruiting
Research Site \| San Giovanni Rotondo, 71013, Italy	Not yet recruiting
Research Site \| Verona, 37126, Italy	Not yet recruiting
Research Site \| Akashi-shi, 674-0063, Japan	Withdrawn
Research Site \| Amagasaki-shi, 660-8550, Japan	Not yet recruiting
Research Site \| Atsugi-shi, 243-0035, Japan	Recruiting
Research Site \| Fujisawa-shi, 251-8550, Japan	Withdrawn
Research Site \| Fukuoka-shi, 815-8555, Japan	Withdrawn
Research Site \| Hachioji-shi, 193-0998, Japan	Withdrawn
Research Site \| Hamamatsu-shi, 430-0906, Japan	Withdrawn
Research Site \| Ina-shi, 396-8555, Japan	Withdrawn
Research Site \| Kanoya-shi, 893-0015, Japan	Recruiting
Research Site \| Kasugai-shi, 486-8510, Japan	Recruiting
Research Site \| Kasugai-shi, 486-8510, Japan	Not yet recruiting
Research Site \| Kitakyushu-shi, 802-8555, Japan	Not yet recruiting
Research Site \| Kitakyushu, 805-8508, Japan	Not yet recruiting
Research Site \| Koga-shi, 306-0041, Japan	Withdrawn
Research Site \| Koto-ku, 136-0075, Japan	Withdrawn
Research Site \| Kumamoto-shi, 861-8520, Japan	Not yet recruiting
Research Site \| Kurashiki shi, 701 0192, Japan	Withdrawn
Research Site \| Kurume-shi, 830-8543, Japan	Withdrawn
Research Site \| Matsumoto-shi, 390-1401, Japan	Withdrawn
Research Site \| Matsuyama-shi, 790-8524, Japan	Not yet recruiting
Research Site \| Morioka-shi, 020-0066, Japan	Withdrawn
Research Site \| Nagano-shi, 380-0928, Japan	Recruiting
Research Site \| Nagoya-shi, 457-8511, Japan	Recruiting
Research Site \| Nagoya-shi, 457-8511, Japan	Not yet recruiting
Research Site \| Nagoya-shi, 466-8650, Japan	Not yet recruiting
Research Site \| Nagoya, 454-0933, Japan	Withdrawn
Research Site \| Naka-shi, 311-0113, Japan	Not yet recruiting
Research Site \| Neyagawa-shi, 572-0015, Japan	Not yet recruiting
Research Site \| Nishinomiya-Shi, 662-0918, Japan	Withdrawn
Research Site \| Noda-shi, 278-8501, Japan	Not yet recruiting
Research Site \| Oita-shi, 870-0033, Japan	Not yet recruiting
Research Site \| Oita-shi, 870-0039, Japan	Recruiting
Research Site \| Omihachiman-shi, 523-0082, Japan	Not yet recruiting
Research Site \| Osaka-shi, 530-0005, Japan	Withdrawn
Research Site \| Osaka-shi, 553-0003, Japan	Withdrawn
Research Site \| Osaka-shi, 558-8558, Japan	Withdrawn
Research Site \| Osaka-shi, 559-0012, Japan	Not yet recruiting
Research Site \| Sakai-shi, 591-8025, Japan	Withdrawn
Research Site \| Sapporo-shi, 006-0811, Japan	Withdrawn
Research Site \| Sashima-gun, 306-0433, Japan	Withdrawn
Research Site \| Shinjuku-ku, 160-0023, Japan	Withdrawn
Research Site \| Shizuoka-shi, 422-8527, Japan	Withdrawn
Research Site \| Tachikawa-shi, 190-8531, Japan	Withdrawn
Research Site \| Takarazuka-shi, 665-0873, Japan	Not yet recruiting
Research Site \| Toyota-Shi, 471-8513, Japan	Recruiting
Research Site \| Toyota-Shi, 471-8513, Japan	Not yet recruiting
Research Site \| Tsuchiura-shi, 300-0028, Japan	Recruiting
Research Site \| Tsuchiura-shi, 300-0028, Japan	Not yet recruiting
Research Site \| Tsuchiura-shi, 300-0835, Japan	Withdrawn
Research Site \| Ueda-shi, 386-8610, Japan	Withdrawn
Research Site \| Yaizu-shi, 425-8505, Japan	Not yet recruiting
Research Site \| Yamagata-shi, 990-8533, Japan	Withdrawn
Research Site \| Yokohama-shi, 236-0004, Japan	Not yet recruiting
Research Site \| Cuauhtemoc, 06700, Mexico	Not yet recruiting
Research Site \| Culiacán, 80230, Mexico	Not yet recruiting
Research Site \| D.F, 14000, Mexico	Not yet recruiting
Research Site \| Guadalajara, 44670, Mexico	Not yet recruiting
Research Site \| Mazatlán, 82000, Mexico	Not yet recruiting
Research Site \| Merida, 97070, Mexico	Not yet recruiting
Research Site \| Merida, 97130, Mexico	Not yet recruiting
Research Site \| Mexico, 03100, Mexico	Not yet recruiting
Research Site \| Mexico, 06700, Mexico	Not yet recruiting
Research Site \| San Luis Potosí, 78250, Mexico	Not yet recruiting
Research Site \| Ponce, 00717, Puerto Rico	Recruiting
Research Site \| Aramil, 624002, Russian Federation	Recruiting
Research Site \| Izhevsk, 426035, Russian Federation	Not yet recruiting
Research Site \| Kazan, 420012, Russian Federation	Not yet recruiting
Research Site \| Moscow, 123182, Russian Federation	Active, not recruiting
Research Site \| Perm, 614000, Russian Federation	Recruiting
Research Site \| Petrozavodsk, 185019, Russian Federation	Withdrawn
Research Site \| Rostov-on-Don, 344022, Russian Federation	Recruiting
Research Site \| Saint Petersburg, 191167, Russian Federation	Recruiting
Research Site \| Saint Petersburg, 194104, Russian Federation	Recruiting
Research Site \| Ufa, 450005, Russian Federation	Recruiting
Research Site \| Voronezh, 394018, Russian Federation	Not yet recruiting
Research Site \| Yaroslavl, 150062, Russian Federation	Withdrawn
Research Site \| Alicante, 03010, Spain	Not yet recruiting
Research Site \| Barcelona, 08035, Spain	Not yet recruiting
Research Site \| Barcelona, 08036, Spain	Not yet recruiting
Research Site \| Barcelona, 8003, Spain	Recruiting
Research Site \| Madrid, 28040, Spain	Not yet recruiting
Research Site \| Madrid, 28041, Spain	Withdrawn
Research Site \| Marbella, 29603, Spain	Withdrawn
Research Site \| Santiago de Compostela, 15706, Spain	Not yet recruiting
Research Site \| Sevilla, 41009, Spain	Recruiting
Research Site \| Tenerife, 38010, Spain	Not yet recruiting
Research Site \| Valencia, 46010, Spain	Recruiting
Research Site \| Valencia, 46014, Spain	Recruiting
Research Site \| Kaohsiung, 833, Taiwan	Not yet recruiting
Research Site \| Keelung, 20448, Taiwan	Recruiting
Research Site \| Keelung, 20448, Taiwan	Not yet recruiting
Research Site \| New Taipei, 23561, Taiwan	Recruiting
Research Site \| Taipei City, 110, Taiwan	Recruiting
Research Site \| Taipei City, 114, Taiwan	Recruiting
Research Site \| Taipei, 10002, Taiwan	Not yet recruiting
Research Site \| Taoyuan, 333, Taiwan	Recruiting
Research Site \| Ankara, 06230, Turkey	Recruiting
Research Site \| Ankara, 06340, Turkey	Recruiting
Research Site \| Ankara, 06340, Turkey	Not yet recruiting
Research Site \| Ankara, 6230, Turkey	Recruiting
Research Site \| Istanbul, 34010, Turkey	Withdrawn
Research Site \| Istanbul, Turkey	Recruiting
Research Site \| Izmir, 35040, Turkey	Recruiting
Research Site \| Izmir, 35040, Turkey	Not yet recruiting
Research Site \| Kahramanmaras, 46100, Turkey	Recruiting
Research Site \| Kahramanmaras, 46100, Turkey	Not yet recruiting
Research Site \| Kayseri, 38039, Turkey	Not yet recruiting
Research Site \| Kocaeli, 41380, Turkey	Recruiting
Research Site \| Dnipropetrovsk, 49005, Ukraine	Recruiting
Research Site \| Dnipropetrovsk, 49005, Ukraine	Not yet recruiting
Research Site \| Kharkiv, 61039, Ukraine	Recruiting
Research Site \| Kharkiv, 61039, Ukraine	Not yet recruiting
Research Site \| Kharkiv, 61103, Ukraine	Not yet recruiting
Research Site \| Kyiv, 01601, Ukraine	Recruiting
Research Site \| Kyiv, 03037, Ukraine	Recruiting
Research Site \| Kyiv, 03057, Ukraine	Not yet recruiting
Research Site \| Kyiv, 03057, Ukraine	Recruiting
Research Site \| Kyiv, 03680, Ukraine	Not yet recruiting
Research Site \| Kyiv, 04050, Ukraine	Recruiting
Research Site \| Kyiv, 04053, Ukraine	Recruiting
Research Site \| Kyiv, 04107, Ukraine	Not yet recruiting
Research Site \| Lutsk, 43005, Ukraine	Recruiting
Research Site \| Vinnytsia, 21009, Ukraine	Not yet recruiting
Research Site \| Vinnytsya, 21028, Ukraine	Recruiting
Research Site \| Zaporizhzhia, 69001, Ukraine	Recruiting
Research Site \| Zhytomyr, 10002, Ukraine	Recruiting
Research Site \| Hanoi, Vietnam	Not yet recruiting
Research Site \| Ho Chi Minh City, 70000, Vietnam	Not yet recruiting
Research Site \| Ho Chi Minh, 700000, Vietnam	Not yet recruiting

Расположение Страны	Argentina Bulgaria China Italy Japan Mexico Puerto Rico Russian Federation Spain Taiwan Turkey Ukraine United States Vietnam
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Ключевые слова	Renal Insufficiency, Chronic Chronic Kidney Diseases Hyperkalemia
Имеет расширенный доступ	No
Состояние Просмотр	Renal Insufficiency, Chronic Renal Insufficiency Hyperkalemia
Количество рук	2
Группа вооружений	Метка: Sodium Zirconium Cyclosilicate (SZC) Тип: Experimental Описание: SZC 5 g every other day to 15 g once daily + Lisinopril/Valsartan Метка: Placebo Тип: Placebo Comparator Описание: Placebo + Lisinopril/Valsartan
Акроним	STABILIZE-CKD
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia