Renal Insufficiency, ChronicPhase 3STABILIZE-CKDNCT05056727
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
A Phase 3 study testing Sodium Zirconium Cyclosilicate (SZC), Lisinopril and Valsartan in people with Renal Insufficiency, Chronic and Hyperkalemia, run by AstraZeneca at 276 sites in 21 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Hyperkalemia
- What is being tested?
- Sodium Zirconium Cyclosilicate (SZC), Lisinopril and Valsartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,112 participants
- Where
- 276 sitesin 21 countries
- Study dates
- 30 Sep 2021to 7 Feb 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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). If the first sample does not fulfil eligibility criteria, a second sample can be obtained during the screening period; if so, the UACR measurement from the second sample must be within the eligibility range.
- Any of the following criteria, a or b, at screening (Visit 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.
Show all 16Show fewer
- 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:
- 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.
- 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.
- 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 (ie, dapagliflozin and canagliflozin), finerenone, or any other medications in these 2 classes that are approved for CKD, 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.
Who cannot join
- 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).
- Participants with a known history of systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg within 2 weeks prior to screening (Visit 1) are excluded. In addition, any participant with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg as measured at screening (Visit 1) and confirmed by repeated measurement is excluded. 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.
Show all 29Show fewer
- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation and heart rate controlled by medication are permitted.
- 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 not approved for CKD 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. Note: For participants taking a fixed combination of an ACEi or ARB with another agent (eg, calcium blockers or diuretics) as SoC, the investigator must make a judgment that it will be safe and efficacious for such participants to change to the study ACEi or ARB and to the other drug as separate agents.
- 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).
Trial locations and contacts
276 sites in 21 countries.
276 sites in 21 countries
China47 sites
Research Site
Baotou, 014010
Research Site
Beijing, 100029
Research Site
Beijing, 100034
Research Site
Beijing, 100044
Research Site
Beijing, 100191
Research Site
Beijing, 102206
Research Site
Beijing, 102218
Research Site
Changchun, 130041
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Chengdu, 610072
Research Site
Chongqing, 400010
Research Site
Guangzhou, 510000
Research Site
Guangzhou, 510062
Research Site
Guangzhou, 510180
Research Site
Guangzhou, 510630
Research Site
Guiyang, 550002
Research Site
Hangzhou, 310014
Research Site
Hefei, 230601
Research Site
Hengyang, 421001
Research Site
Huizhou, 516001
Research Site
Lanzhou, 730030
Research Site
Nanchang, 330006
Research Site
Nanjing, 210009
Research Site
Nanjing, 210011
Research Site
Nanjing, 210029
Research Site
Ningbo, 315010
Research Site
Sanya, 572000
Research Site
Shanghai, 200025
Research Site
Shanghai, 200040
Research Site
Shanghai, 201199
Research Site
Shanghai, 201210
Research Site
Shantou, 515041
Research Site
Shengyang, 110004
Research Site
Shenyang, 110001
Research Site
Shenzhen, 518036
Research Site
Taiyuan, 030012
Research Site
Ürümqi, 830054
Research Site
Wuhan, 430010
Research Site
Wuhan, 430060
Research Site
Wuxi, 214023
Research Site
Xi'an, 710061
Research Site
Xuzhou, 221000
Research Site
Yantai, 264000
Research Site
Yinchuan, 750004
Research Site
Zhengzhou, 450052
Research Site
Zhuzhou, 412007
United States42 sites
Research Site
Albany, New York, 12205
Research Site
Albuquerque, New Mexico, 87109
Research Site
Arlington, Texas, 76015
Research Site
Bethlehem, Pennsylvania, 18017
Research Site
Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
Research Site
Boynton Beach, Florida, 33435
Research Site
Canyon Country, California, 91351
Research Site
Chattanooga, Tennessee, 37404
Research Site
Chester, Pennsylvania, 19013
Research Site
Chicago, Illinois, 60643
Research Site
Chula Vista, California, 91910
Research Site
Cincinnati, Ohio, 45267
Research Site
Columbia, Missouri, 65201
Research Site
Columbia, South Carolina, 29203
Research Site
Denver, Colorado, 80230
Research Site
Flint, Michigan, 48532
Research Site
Fort Wayne, Indiana, 46804
Research Site
Fort Worth, Texas, 76164
Research Site
Great Neck, New York, 11021
Research Site
Hialeah, Florida, 33012
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77054
Research Site
Houston, Texas, 77099
Research Site
Kansas City, Missouri, 64111
Research Site
Lauderdale Lakes, Florida, 33313
Research Site
Louisville, Kentucky, 40205
Research Site
Nampa, Idaho, 83687
Research Site
Newport News, Virginia, 23606
Research Site
Northridge, California, 91324
Research Site
Oak Brook, Illinois, 60523
Research Site
Ocoee, Florida, 34761
Research Site
Orangeburg, South Carolina, 29118
Research Site
Saint Clair Shores, Michigan, 48081
Research Site
San Antonio, Texas, 78212
Research Site
San Dimas, California, 91773
Research Site
South Gate, California, 90280
Research Site
Surprise, Arizona, 85374
Research Site
Tarzana, California, 91356
Research Site
Temple Terrace, Florida, 33637
Research Site
Tucson, Arizona, 85741
Research Site
Winston-Salem, North Carolina, 27103
Japan42 sites
Research Site
Amagasaki-shi, 660-8550
Research Site
Atsugi-shi, 243-0035
Research Site
Chiba, 260-8712
Research Site
Chuo-shi, 409-3898
Research Site
Chūōku, 103-0002
Research Site
Chūōku, 104-8560
Research Site
Fukuoka, 814-0180
Research Site
Kamakura-shi, 247-0056
Research Site
Kanoya-shi, 893-0015
Research Site
Kasugai-shi, 486-8510
Research Site
Kawachinagano-shi, 586-8521
Research Site
Kawasaki-shi, 211-8510
Research Site
Kitakyushu, 805-8508
Research Site
Kitakyushu-shi, 802-8555
Research Site
Koriyama-shi, 963-8052
Research Site
Koshigaya-shi, 343-8555
Research Site
Kumamoto, 861-8520
Research Site
Kure-shi, 737-0023
Research Site
Marugame-shi, 763-8502
Research Site
Matsumoto-shi, 390-8621
Research Site
Matsusaka-shi, 515-8557
Research Site
Matsuyama, 790-8524
Research Site
Nagoya, 457-8511
Research Site
Nagoya, 466-8650
Research Site
Naka, 311-0113
Research Site
Noda, 278-8501
Research Site
Ōita, 870-0033
Research Site
Ōmihachiman, 523-0082
Research Site
Osaka, 543-8922
Research Site
Osaka, 559-0012
Research Site
Sakaishi, 593-8304
Research Site
Takarazuka-shi, 665-0873
Research Site
Toyota, 470-0396
Research Site
Toyota-Shi, 471-8513
Research Site
Tsu, 514-8507
Research Site
Tsuchiura-shi, 300-0028
Research Site
Urayasu-shi, 279-0021
Research Site
Yaizu-shi, 425-8505
Research Site
Yokohama, 227-8501
Research Site
Yokohama, 234-0054
Research Site
Yokohama, 236-0004
Research Site
Yonago-shi, 683-8605
Bulgaria18 sites
Research Site
Blagoevgrad, 2700
Research Site
Botevgrad, 2140
Research Site
Dupnitsa, 2600
Research Site
Gorna Oryahovitsa, 5100
Research Site
Gotse Delchev, 2900
Research Site
Kozloduy, 3320
Research Site
Lom, 3600
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4001
Research Site
Plovdiv, 4004
Research Site
Samokov, 2000
Research Site
Sandanski, 2800
Research Site
Silistra, 7500
Research Site
Sliven, 8800
Research Site
Smolyan, 3700
Research Site
Stara Zagora, 6000
Research Site
Yambol, 8600
Taiwan15 sites
Research Site
Hualien City, 97002
Research Site
Kaohsiung City, 81362
Research Site
Kaohsiung City, 82445
Research Site
Kaohsiung City, 833
Research Site
Keelung, 20448
Research Site
New Taipei City, 220216
Research Site
New Taipei City, 23561
Research Site
Taichung, 40201
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Tainan, 710
Research Site
Taipei, 10002
Research Site
Taipei, 110
Research Site
Taipei, 114
Research Site
Taoyuan, 333
Spain12 sites
Research Site
Almería, 4009
Research Site
Barcelona, 08035
Research Site
Barcelona, 08036
Research Site
Barcelona, 8003
Research Site
Getafe, 28905
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Lugo, 27004
Research Site
Madrid, 28040
Research Site
Santa Cruz de Tenerife, 38010
Research Site
Seville, 41009
Research Site
Valencia, 46010
Research Site
Valencia, 46014
Italy11 sites
Research Site
Bari, 70124
Research Site
Bassano del Grappa, 36061
Research Site
Bologna, 40138
Research Site
Brescia, 25123
Research Site
Messina, 98125
Research Site
Pavia, 27100
Research Site
Roma, 00161
Research Site
Roma, 00168
Research Site
Rozzano, 20089
Research Site
San Giovanni Rotondo, 71013
Research Site
Verona, 37126
Turkey (Türkiye)11 sites
Research Site
Adapazarı, 54100
Research Site
Ankara, 06230
Research Site
Ankara, 06340
Research Site
Ankara, 6230
Research Site
Antalya, 07059
Research Site
Gaziantep, 27310
Research Site
Istanbul
Research Site
Izmir, 35040
Research Site
Kahramanmaraş, 46100
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380
Mexico10 sites
Research Site
Cuauhtémoc, 06700
Research Site
Culiacán, 80230
Research Site
Guadalajara, 44670
Research Site
Mazatlán, 82000
Research Site
Mérida, 97070
Research Site
Mérida, 97130
Research Site
México, 03100
Research Site
México, 06700
Research Site
San Luis Potosí City, 78250
Research Site
Veracruz, 91900
Ukraine10 sites
Research Site
Dnipropetrovsk, 49005
Research Site
Kharkiv, 61039
Research Site
Kyiv, 02125
Research Site
Kyiv, 03057
Research Site
Kyiv, 04050
Research Site
Kyiv, 04053
Research Site
Lutsk, 43005
Research Site
Vinnytsia, 21028
Research Site
Zaporizhzhya, 69001
Research Site
Zhytomyr, 10002
Argentina9 sites
Research Site
Buenos Aires, ARG 1425
Research Site
Buenos Aires, C1429BWN
Research Site
CABA, C1440AAD
Research Site
La Plata, 1900
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600
Research Site
Rosario, 2000
Research Site
San Vicente, 5006
Research Site
Sarandí, B1872EEC
Brazil8 sites
Research Site
Curitiba, 80440-020
Research Site
Fortaleza, 60115282
Research Site
Joinville, 89227-680
Research Site
Maringá, 87060-040
Research Site
Porto Alegre, 90020-090
Research Site
Porto Alegre, 90160-093
Research Site
São Paulo, 04039-000
Research Site
São Paulo, 05403-9000
Malaysia8 sites
Research Site
Alor Star, 5460
Research Site
Batu Caves, 68100
Research Site
Johor Bahru, 80100
Research Site
Kajang, 43000
Research Site
Kuala Lumpur, 50586
Research Site
Kuala Lumpur, 56000
Research Site
Kuala Lumpur, 59100
Research Site
Seri Manjung, 32040
Vietnam7 sites
Research Site
Bien Hoa, 810000
Research Site
Da Nang, 55000
Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 10000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000
Research Site
Huế, 530000
Poland5 sites
Research Site
Krakow, 31-156
Research Site
Lodz, 92-213
Research Site
Poznan, 61-485
Research Site
Rzeszów, 35-055
Research Site
Tczew, 83-110
Russia5 sites
Research Site
Aramil, 624002
Research Site
Moscow, 123182
Research Site
Perm, 614000
Research Site
Rostov-on-Don, 344022
Research Site
Saint Petersburg, 191167
Thailand5 sites
Research Site
Bangkok, 10330
Research Site
Bangkok, 10700
Research Site
Chaingmai, 50200
Research Site
Hat Yai, 90110
Research Site
Ratchathewi, 10400
Canada4 sites
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Oshawa, Ontario, L1G 2B9
Research Site
Saint John, New Brunswick, E2L 4L2
India4 sites
Research Site
Coimbatore, 641018
Research Site
Kolkata, 700020
Research Site
Madurai, 625107
Research Site
New Delhi, 110029
Philippines2 sites
Research Site
Davao City, PH-8000
Research Site
Iloilo City, 5000
About this study
Official title: A Phase 3, International, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on CKD Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia
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.
Read the detailed description
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.
- Conditions
- Renal Insufficiency, Chronic, Hyperkalemia
- Being tested
- Sodium Zirconium Cyclosilicate (SZC), Placebo, Lisinopril, Valsartan, Irbesartan
- Keywords
- Renal Insufficiency, Chronic, Chronic Kidney Diseases, Hyperkalemia
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Zirconium Cyclosilicate (SZC)Drug
Also called Lokelma TM
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. The 10 g SZC single dose should be administered three times daily for up to 72 hours until normokalaemic (S-K 3.5-5.0 mmol/L); the total daily dose is 30 g SZC.
- 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.
PlaceboDrug
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.
LisinoprilDrug
Tablet for oral administration. Unit dose strength: 2.5, 5, 10 or 20 mg. Dosage level: 5, 10, 20, or 40 mg administered once daily.
ValsartanDrug
Tablet or capsule for oral administration. Unit dose strength: 40, 80 or 160 mg. Dosage level: 40, 80, 160, or 320 mg administered once daily.
IrbesartanDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Zirconium Cyclosilicate (SZC) | Experimental | SZC 5 g every other day to 15 g once daily + Lisinopril/Valsartan Receives: Drug: Sodium Zirconium Cyclosilicate (SZC); Drug: Lisinopril; Drug: Valsartan; Drug: Irbesartan |
| Placebo | Placebo comparator | Placebo + Lisinopril/Valsartan Receives: Drug: Placebo; Drug: Lisinopril; Drug: Valsartan; Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total eGFR Slope (Coprimary Analysis #1)
Total eGFR slope, Baseline (Maintenance phase) to visit 17 (week 69)
Measured: Baseline (Maintenance phase) to visit 17 (week 69)
Chronic eGFR Slope (Coprimary Analysis #2)
Chronic eGFR slope, 12 weeks to visit 17 (week 69)
Measured: 12 weeks to visit 17 (week 69)
Secondary outcomes (3)
Incidence of the Composite of Kidney Failure Outcomes
Incidence of the composite of kidney failure outcomes comprising: sustained ≥ 40% decline in eGFR, onset of ESKD, and death from kidney failure is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.
Measured: From Baseline (Maintenance phase) up to week 97 (Maintenance phase)
Incidence of RAASi Reduction
Incidence of RAASi (lisinopril/valsartan) dose decrease is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.
Measured: From Baseline (Maintenance phase) up to week 97 (Maintenance phase)
UACR
Urine albumin-to-creatinine ratio (UACR); mass concentration of albumin divided by mass concentration of creatinine, in urine; at visit 13 (week 24)
Measured: At visit 13 (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start30 Sep 2021
- Primary completion7 Feb 2024
- Study completion7 Feb 2024
Why it stopped: The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn M. Chertow, MD, MPH, Principal investigator, Stanford University School of Medicine, Stanford, CA USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056727
- Sponsor's protocol ID
- D9488C00001
- Other IDs
- 2021-001911-96
- Acronym
- STABILIZE-CKD
- Status last verified
- Dec 2025
- First submitted
- 1 Sep 2021
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.