Kidney drug trial halted: did it help or harm?

NCT ID NCT05056727

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called sodium zirconium cyclosilicate (SZC) to see if it could slow down chronic kidney disease (CKD) in people who also have high potassium levels. Over 1,100 adults with moderate-to-severe CKD took SZC or a placebo alongside their regular blood pressure medications. The trial was stopped early, so the full results are not available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,112 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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): 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 (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. 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). * 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. * 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).

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome Hyperkalemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyperkalemia Renal insufficiency, chronic

Contacts and locations

Locations

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Surprise, Arizona, 85374, United States
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Tucson, Arizona, 85741, United States
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Canyon Country, California, 91351, United States
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Chula Vista, California, 91910, United States
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Northridge, California, 91324, United States
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San Dimas, California, 91773, United States
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South Gate, California, 90280, United States
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Tarzana, California, 91356, United States
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Denver, Colorado, 80230, United States
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Boynton Beach, Florida, 33435, United States
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Hialeah, Florida, 33012, United States
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Lauderdale Lakes, Florida, 33313, United States
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Ocoee, Florida, 34761, United States
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Temple Terrace, Florida, 33637, United States
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Nampa, Idaho, 83687, United States
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Chicago, Illinois, 60643, United States
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Oak Brook, Illinois, 60523, United States
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Fort Wayne, Indiana, 46804, United States
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Louisville, Kentucky, 40205, United States
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Boston, Massachusetts, 02114, United States
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Boston, Massachusetts, 02115, United States
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Flint, Michigan, 48532, United States
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Saint Clair Shores, Michigan, 48081, United States
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Columbia, Missouri, 65201, United States
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Kansas City, Missouri, 64111, United States
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Albuquerque, New Mexico, 87109, United States
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Albany, New York, 12205, United States
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Great Neck, New York, 11021, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45267, United States
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Bethlehem, Pennsylvania, 18017, United States
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Chester, Pennsylvania, 19013, United States
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Columbia, South Carolina, 29203, United States
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Orangeburg, South Carolina, 29118, United States
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Chattanooga, Tennessee, 37404, United States
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Arlington, Texas, 76015, United States
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Fort Worth, Texas, 76164, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77099, United States
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San Antonio, Texas, 78212, United States
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Newport News, Virginia, 23606, United States
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Buenos Aires, ARG 1425, Argentina
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Buenos Aires, C1429BWN, Argentina
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CABA, C1440AAD, Argentina
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La Plata, 1900, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600, Argentina
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Rosario, 2000, Argentina
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San Vicente, 5006, Argentina
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Sarandí, B1872EEC, Argentina
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Curitiba, 80440-020, Brazil
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Fortaleza, 60115282, Brazil
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Joinville, 89227-680, Brazil
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Maringá, 87060-040, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90160-093, Brazil
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São Paulo, 04039-000, Brazil
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São Paulo, 05403-9000, Brazil
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Blagoevgrad, 2700, Bulgaria
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Botevgrad, 2140, Bulgaria
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Dupnitsa, 2600, Bulgaria
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Gorna Oryahovitsa, 5100, Bulgaria
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Gotse Delchev, 2900, Bulgaria
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Kozloduy, 3320, Bulgaria
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Lom, 3600, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4000, Bulgaria
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Plovdiv, 4001, Bulgaria
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Plovdiv, 4004, Bulgaria
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Samokov, 2000, Bulgaria
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Sandanski, 2800, Bulgaria
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Silistra, 7500, Bulgaria
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Sliven, 8800, Bulgaria
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Smolyan, 3700, Bulgaria
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Stara Zagora, 6000, Bulgaria
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Yambol, 8600, Bulgaria
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Saint John, New Brunswick, E2L 4L2, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Baotou, 014010, China
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Beijing, 100029, China
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Beijing, 100034, China
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Beijing, 100044, China
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Beijing, 100191, China
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Beijing, 102206, China
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Beijing, 102218, China
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Changchun, 130041, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chengdu, 610072, China
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Chongqing, 400010, China
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Guangzhou, 510000, China
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Guangzhou, 510062, China
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Guangzhou, 510180, China
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Guangzhou, 510630, China
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Guiyang, 550002, China
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Hangzhou, 310014, China
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Hefei, 230601, China
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Hengyang, 421001, China
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Huizhou, 516001, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Nanjing, 210009, China
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Nanjing, 210011, China
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Nanjing, 210029, China
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Ningbo, 315010, China
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Sanya, 572000, China
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Shanghai, 200025, China
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Shanghai, 200040, China
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Shanghai, 201199, China
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Shanghai, 201210, China
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Shantou, 515041, China
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Shengyang, 110004, China
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Shenyang, 110001, China
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Shenzhen, 518036, China
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Taiyuan, 030012, China
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Ürümqi, 830054, China
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Wuhan, 430010, China
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Wuhan, 430060, China
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Wuxi, 214023, China
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Xi'an, 710061, China
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Xuzhou, 221000, China
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Yantai, 264000, China
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Yinchuan, 750004, China
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Zhengzhou, 450052, China
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Zhuzhou, 412007, China
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Coimbatore, 641018, India
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Kolkata, 700020, India
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Madurai, 625107, India
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New Delhi, 110029, India
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Bari, 70124, Italy
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Bassano del Grappa, 36061, Italy
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Messina, 98125, Italy
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Pavia, 27100, Italy
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Roma, 00161, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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San Giovanni Rotondo, 71013, Italy
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Verona, 37126, Italy
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Amagasaki-shi, 660-8550, Japan
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Atsugi-shi, 243-0035, Japan
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Chiba, 260-8712, Japan
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Chuo-shi, 409-3898, Japan
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Chūōku, 103-0002, Japan
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Chūōku, 104-8560, Japan
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Fukuoka, 814-0180, Japan
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Kamakura-shi, 247-0056, Japan
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Kanoya-shi, 893-0015, Japan
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Kasugai-shi, 486-8510, Japan
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Kawachinagano-shi, 586-8521, Japan
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Kawasaki-shi, 211-8510, Japan
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Kitakyushu, 805-8508, Japan
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Kitakyushu-shi, 802-8555, Japan
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Koriyama-shi, 963-8052, Japan
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Koshigaya-shi, 343-8555, Japan
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Kumamoto, 861-8520, Japan
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Kure-shi, 737-0023, Japan
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Marugame-shi, 763-8502, Japan
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Matsumoto-shi, 390-8621, Japan
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Matsusaka-shi, 515-8557, Japan
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Matsuyama, 790-8524, Japan
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Nagoya, 457-8511, Japan
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Nagoya, 466-8650, Japan
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Naka, 311-0113, Japan
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Noda, 278-8501, Japan
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Osaka, 543-8922, Japan
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Osaka, 559-0012, Japan
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Ōita, 870-0033, Japan
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Ōmihachiman, 523-0082, Japan
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Sakaishi, 593-8304, Japan
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Takarazuka-shi, 665-0873, Japan
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Toyota, 470-0396, Japan
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Toyota-Shi, 471-8513, Japan
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Tsu, 514-8507, Japan
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Tsuchiura-shi, 300-0028, Japan
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Urayasu-shi, 279-0021, Japan
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Yaizu-shi, 425-8505, Japan
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Yokohama, 227-8501, Japan
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Yokohama, 234-0054, Japan
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Yokohama, 236-0004, Japan
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Yonago-shi, 683-8605, Japan
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Alor Star, 5460, Malaysia
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Batu Caves, 68100, Malaysia
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Johor Bahru, 80100, Malaysia
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Kajang, 43000, Malaysia
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Kuala Lumpur, 50586, Malaysia
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Kuala Lumpur, 56000, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Seri Manjung, 32040, Malaysia
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Cuauhtémoc, 06700, Mexico
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Culiacán, 80230, Mexico
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Guadalajara, 44670, Mexico
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Mazatlán, 82000, Mexico
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Mérida, 97070, Mexico
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Mérida, 97130, Mexico
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México, 03100, Mexico
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México, 06700, Mexico
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San Luis Potosí City, 78250, Mexico
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Veracruz, 91900, Mexico
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Davao City, PH-8000, Philippines
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Iloilo City, 5000, Philippines
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Krakow, 31-156, Poland
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Lodz, 92-213, Poland
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Poznan, 61-485, Poland
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Rzeszów, 35-055, Poland
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Tczew, 83-110, Poland
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Ponce, 00717, Puerto Rico
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Aramil, 624002, Russia
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Moscow, 123182, Russia
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Perm, 614000, Russia
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Rostov-on-Don, 344022, Russia
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Saint Petersburg, 191167, Russia
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Almería, 4009, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 8003, Spain
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Getafe, 28905, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Lugo, 27004, Spain
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Madrid, 28040, Spain
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Santa Cruz de Tenerife, 38010, Spain
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Seville, 41009, Spain
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Valencia, 46010, Spain
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Valencia, 46014, Spain
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Hualien City, 97002, Taiwan
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Kaohsiung City, 81362, Taiwan
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Kaohsiung City, 82445, Taiwan
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Kaohsiung City, 833, Taiwan
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Keelung, 20448, Taiwan
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New Taipei City, 220216, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 40201, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Tainan, 710, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 110, Taiwan
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Taipei, 114, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10330, Thailand
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Bangkok, 10700, Thailand
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Chaingmai, 50200, Thailand
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Hat Yai, 90110, Thailand
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Ratchathewi, 10400, Thailand
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Adapazarı, 54100, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06340, Turkey (Türkiye)
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Ankara, 6230, Turkey (Türkiye)
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Antalya, 07059, Turkey (Türkiye)
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Gaziantep, 27310, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, 35040, Turkey (Türkiye)
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Kahramanmaraş, 46100, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Dnipropetrovsk, 49005, Ukraine
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Kharkiv, 61039, Ukraine
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Kyiv, 02125, Ukraine
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Kyiv, 03057, Ukraine
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Kyiv, 04050, Ukraine
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Kyiv, 04053, Ukraine
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Lutsk, 43005, Ukraine
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Vinnytsia, 21028, Ukraine
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Zaporizhzhia, 69001, Ukraine
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Zhytomyr, 10002, Ukraine
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Bien Hoa, 810000, Vietnam
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Da Nang, 55000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 10000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Ho Chi Minh City, 70000, Vietnam
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Huế, 530000, Vietnam

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