New pill combo aims to slow kidney decline in High-Risk patients

NCT ID NCT06087835

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding zibotentan to the standard drug dapagliflozin can better protect kidney function in people with chronic kidney disease and high proteinuria. About 1,800 adults are taking either the combo or dapagliflozin alone. The main goal is to see if the combo slows the drop in kidney filtering rate over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Zibotentan and Dapagliflozin combination
What this could lead to: If successful, this combination could slow kidney function decline better than current standard care, potentially delaying the need for dialysis or transplant.
What could go wrong: This is a Phase 3 trial, but results are not yet available. The combination may not prove superior to dapagliflozin alone, and side effects from adding zibotentan are possible.

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

1,835 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Feb 2027

An estimate. End dates often move.

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 95 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: 1. Participant must be ≥ 18 years of age and of legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. 2. Diagnosis of CKD, defined as eGFR ≥ 20 and \< 90 mL/min/1.73 m2 and UACR \> 700 mg/g (\> 79 mg/mmol) or UPCR \> 1000 mg/g (\> 113 mg/mmoL). 3. All female participants must have a negative serum pregnancy test result at screening. 4. Female participants must be either * not of child-bearing potential or * women of child bearing potential (WOCBP) using at least one highly effective birth control method for at least 3 months prior to first dose of study intervention 5. Capable of giving signed informed consent 6. Provision of signed informed consent prior to any study specific procedure. 7. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ). 8. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics imitative research that supports the Genomic Initiative. 9. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks. Exclusion Criteria: 1. Participants with NYHA class III or class IV Congestive HF at the time of enrolment. 2. Participants hospitalised for HF during the last 6 month prior to screening. 3. Evidence of rales or jugular venous distention on physical examination. 4. Participants with type 1 diabetes mellitus. 5. History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal). 6. Blood pressure above 160 mmHg systolic. 7. Blood pressure below 90 mmHg systolic. 8. Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening. 9. History of solid organ transplantation or bone marrow transplant. 10. History or ongoing allergy/hypersensitivity, as judged by the Investigator, to SGLT2i therapy (eg, dapagliflozin, canagliflozin, empagliflozin or other SGLT2 inhibitors) or Endothelin Receptor Antagonists (eg, ambrisentan, atrasentan, bosentan, or other). 11. Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment. 12. Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ. 13. Significant liver disease as judged by the investigator or severe hepatic impairment with AST or ALT \> 3 × ULN; or total bilirubin \> 2 × ULN at time of screening. An isolated increase in bilirubin in participants with known Gilbert's syndrome is not a reason for exclusion. 14. Known blood-borne diseases. 15. Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator. 16. Participants on renal replacement therapy or previous kidney transplant. 17. Known history of drug or alcohol abuse within 12 months of screening. 18. Participants on treatment with strong or moderate CYP3A4 inducer. 19. Participants on systemic immunosuppression therapy other than stable maintenance therapy defined as prednisone 10 mg/day (or equivalent) or less, aziothioprine 100 mg/day or less; MMF 1000 mg/day or less for at least 3 months prior to Visit 1. Inhaled, nasal or dermatological steroids are also allowed. 20. Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN). 21. Participation in another clinical study with a study intervention administered in the last 3 months. 22. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 23. Inability of the participant, in the opinion of the investigator, to understand and/or comply with IMP, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the participant unable to complete the study. 24. Previous randomisation in the present study. 25. Women who are pregnant, breast-feeding, or women with intent of getting pregnant. 26. Women who are not willing to use adequate contraception or cannot, in the opinion of the investigator, understand and/or comply with the study procedures.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease kidney disorder

As listed by the trial registrant

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

Chronic kidney disease with high proteinuria

Contacts and locations

Locations

Research Site

Huntsville, Alabama, 35805, United States
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Sun City West, Arizona, 85375, United States
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Bakersfield, California, 93309, United States
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Huntington Park, California, 90255, United States
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Los Alamitos, California, 90720, United States
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Los Angeles, California, 90010, United States
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Northridge, California, 91324, United States
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Oxnard, California, 93036, United States
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San Carlos, California, 94070, United States
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San Dimas, California, 91773, United States
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Tarzana, California, 91356, United States
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Victorville, California, 92392, United States
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Arvada, Colorado, 80002, 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, 33016, United States
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Hollywood, Florida, 33024, United States
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Jacksonville, Florida, 32204, United States
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Jensen Beach, Florida, 34957, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33165, United States
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Orlando, Florida, 32806, United States
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Fayetteville, Georgia, 30214, United States
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Champaign, Illinois, 61822, United States
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Chicago, Illinois, 60616, United States
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Hinsdale, Illinois, 60521, United States
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Island Lake, Illinois, 60042, United States
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Skokie, Illinois, 60077, United States
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Bowling Green, Kentucky, 42101, United States
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Shreveport, Louisiana, 71101, United States
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Silver Spring, Maryland, 20901, United States
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Flint, Michigan, 48504, United States
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Flint, Michigan, 48532, United States
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Troy, Michigan, 48098, United States
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City of Saint Peters, Missouri, 63376, United States
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Albany, New York, 12205, United States
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Middletown, New York, 10940, United States
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Orchard Park, New York, 14127, United States
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Greenville, North Carolina, 27834, United States
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Jacksonville, North Carolina, 28546, United States
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Kinston, North Carolina, 28504, United States
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New Bern, North Carolina, 28562, United States
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Statesville, North Carolina, 28625, United States
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Wilmington, North Carolina, 28401, United States
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Wilmington, North Carolina, 28412, United States
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Winston-Salem, North Carolina, 27103, United States
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Maumee, Ohio, 43537, United States
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Pottstown, Pennsylvania, 19464, United States
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East Providence, Rhode Island, 02915, United States
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Kingsport, Tennessee, 37660, United States
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Arlington, Texas, 76015, United States
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Austin, Texas, 78726, United States
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Houston, Texas, 77004, United States
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Houston, Texas, 77099, United States
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Pearland, Texas, 77584, United States
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San Antonio, Texas, 78204, United States
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San Antonio, Texas, 78207, United States
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San Antonio, Texas, 78212, United States
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Sugar Land, Texas, 77478, United States
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South Salt Lake, Utah, 84115, United States
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Alexandria, Virginia, 22311, United States
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Newport News, Virginia, 23606, United States
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Mukilteo, Washington, 98275, United States
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Spokane, Washington, 99202, United States
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Ciudad de Buenos Aires, 1280, Argentina
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Ciudad de Buenos Aires, C1425AGC, Argentina
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Mar del Plata, 7600, Argentina
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Mar del Plata, B7600, Argentina
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Santa Fe, S3000, Argentina
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Gosford, 2250, Australia
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Meadowbrook, 4131, Australia
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Perth, 6000, Australia
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Reservoir, 3021, Australia
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Reservoir, 3073, Australia
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Southport, 4222, Australia
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Feldkirch, 6800, Austria
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Vienna, 1130, Austria
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Belém, 66073-005, Brazil
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Botucatu, 18618-687, Brazil
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Joinville, 89227-680, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01228-200, Brazil
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São Paulo, 04012-909, Brazil
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São Paulo, 04038-031, Brazil
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Dobrich, 9300, 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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Sofia, 1680, Bulgaria
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Stara Zagora, 6000, Bulgaria
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London, Ontario, N6A 5A5, Canada
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Waterloo, Ontario, N2T 0C1, Canada
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Greenfield Park, Quebec, J4V 2H1, 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, 102218, China
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Changsha, 410013, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Chongqing, 400010, China
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Deyang, 618000, China
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Foshan, 528000, China
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Guangzhou, 510120, China
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Guangzhou, 510515, China
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Hangzhou, 310014, China
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Hengyang, 421001, China
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Linhai, 317000, China
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Nanjing, 210009, China
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Nanjing, 210011, China
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Nanning, 530022, China
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Ningbo, 315010, China
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Pingxiang, 337055, China
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Shanghai, 200240, China
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Shantou, 515041, China
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Shenzhen, 518039, China
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Shenzhen, 518053, China
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Wenzhou, 325000, China
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Wuhan, 430010, China
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Wuxi, 214000, China
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Xi'an, 710061, China
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Xiamen, 361101, China
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Yantai, 264000, China
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Yibin, 610500, China
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Yinchuan, 750004, China
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Zhuzhou, 412007, China
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Zigong, 643000, China
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Aalborg, 9100, Denmark
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Aarhus, 8200, Denmark
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Herlev, 2730, Denmark
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Herning, 7400, Denmark
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Roskilde, 4000, Denmark
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La Tronche, 38700, France
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Mulhouse, 68100, France
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Nice, 06000, France
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Nîmes, 30000, France
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Rouen, 76031, France
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Saint-Priest-en-Jarez, 42270, France
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Strasbourg, 67090, France
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Tours, 37000, France
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Aachen, 52074, Germany
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Bad Oeynhausen, 32545, Germany
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Berlin, 10117, Germany
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Dresden, 01279, Germany
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Hanover, 30625, Germany
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Mainz, 55131, Germany
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München, 80336, Germany
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Bangalore, 560060, India
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Belagavi, 590010, India
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Delhi, 110029, India
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Nadiād, 387001, India
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New Delhi, 110017, India
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Ashkelon, 78278, Israel
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Haifa, 3109601, Israel
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Jerusalem, 9372212, Israel
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Kfar Saba, 44281, Israel
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Nahariya, 22100, Israel
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Petah Tikva, 49372, Israel
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Ramat Gan, 52621, Israel
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Rehovot, 76100, Israel
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Bergamo, 24127, Italy
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Bologna, 40138, Italy
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Foggia, 71100, Italy
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Genoa, 16132, Italy
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Naples, 80138, Italy
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Pisa, 56124, Italy
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Roma, 161, Italy
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Torino, 10126, Italy
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Chūōku, 103-0027, Japan
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Fujisawa-shi, 251-0041, Japan
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Fukui-shi, 910-8526, Japan
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Fukuoka, 810-0001, Japan
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Fukuoka, 810-8563, Japan
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Fukuoka, 819-0168, Japan
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Hashima-gun, 501-6061, Japan
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Kamakura-shi, 247-0056, Japan
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Kasuga-shi, 816-0864, Japan
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Kawaguchi-shi, 332-0012, Japan
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Kitakyushu-shi, 802-8555, Japan
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Kitakyusyu-shi, 806-8501, Japan
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Kofu, 400-8506, Japan
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Kurume-shi, 830-0011, Japan
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Kurume-shi, 830-8543, Japan
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Kusatsu-shi, 525-8585, Japan
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Kyoto, 607-8062, Japan
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Matsumoto-shi, 390-8510, Japan
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Meguro-ku, 153-0061, Japan
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Minatoku, 108-0073, Japan
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Minokamo Shi, 505-8510, Japan
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Nishinomiya-shi, 662-0971, Japan
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Nishinomiya-shi, 663-8241, Japan
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Okawa-shi, 831-0016, Japan
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Osaka, 550-0006, Japan
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Osaka, 559-0012, Japan
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Oyama-shi, 323-0022, Japan
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Sakushu, 385-8558, Japan
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Sapporo, 003-0026, Japan
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Sapporo, 062-0931, Japan
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Sendai, 980-8574, Japan
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Soka-shi, 340-0015, Japan
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Takamatsu, 760-0076, Japan
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Takasago-shi, 676-0812, Japan
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Tondabayashi-shi, 584-0082, Japan
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Toride-shi, 302-0022, Japan
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Urayasu, 279-0001, Japan
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Utsunomiya, 320-8580, Japan
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Alor Star, 5460, Malaysia
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Ipoh, 30990, Malaysia
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Kota Kinabalu, 88200, Malaysia
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Kuala Lumpur, 59100, Malaysia
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Seremban, 70300, Malaysia
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Seri Manjung, 32040, Malaysia
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Mazatlán, 82127, Mexico
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Amersfoort, 3813 TZ, Netherlands
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Breda, 4818 CK, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Bodø, 8073, Norway
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Lørenskog, 1478, Norway
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Oslo, 0450, Norway
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Stavanger, 4011, Norway
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Tromsø, 9019, Norway
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Chrzanów, 32-500, Poland
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Krakow, 31-156, Poland
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Krakow, 31-501, Poland
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Lodz, 92-213, Poland
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Poznan, 60-354, Poland
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Radom, 26-600, Poland
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Rzeszów, 35-055, Poland
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Szczecin, 70-111, Poland
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Warsaw, 03-291, Poland
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Lučenec, 984 01, Slovakia
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Prešov, 080 01, Slovakia
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Púchov, 020 01, Slovakia
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Rožňava, 048 01, Slovakia
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Trebišov, 07501, Slovakia
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Benoni, 1501, South Africa
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Cape Town, 7925, South Africa
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Chatsworth, 4092, South Africa
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Durban, 4450, South Africa
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Lenasia, 1827, South Africa
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Midrand, 1685, South Africa
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Parow, 7505, South Africa
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Ansan-si, 15355, South Korea
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Busan, 49241, South Korea
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Cheonan-si, 31151, South Korea
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Daegu, 41944, South Korea
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Goyang-si, 10380, South Korea
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Seoul, 06591, South Korea
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Seoul, 120-752, South Korea
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Seoul, 156-707, South Korea
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Girona, 17007, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Lugo, 27004, Spain
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Madrid, 28041, Spain
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Majadahonda, 28222, Spain
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Seville, 41071, Spain
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Valencia, 46010, Spain
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Gothenburg, 413 46, Sweden
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Linköping, 581 85, Sweden
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Rättvik, 79530, Sweden
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Stockholm, 141 86, Sweden
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Uppsala, 751 85, Sweden
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Kaohsiung City, 807, Taiwan
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Kaohsiung City, 833, Taiwan
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New Taipei City, 220, Taiwan
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Taichung, 407219, 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, 11490, 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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Khon Kaen, 40002, 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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Bursa, 16059, Turkey (Türkiye)
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Dinar, 03400, Turkey (Türkiye)
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Kahramanmaraş, 46040, Turkey (Türkiye)
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Kayseri, 38039, Turkey (Türkiye)
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Kocaeli, 41380, Turkey (Türkiye)
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Cardiff, CF14 4XW, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Glasgow, G51 4TF, United Kingdom
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London, E1 1BB, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SE5 9RJ, United Kingdom
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York, YO21 8HE, United Kingdom
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Haiphong, 180000, Vietnam
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Hanoi, 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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Ho Chi Minh City, Vietnam

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