Chronic Kidney Disease With High ProteinuriaPhase 3NCT06087835
Study to Investigate Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin in Participants With Chronic Kidney Disease and High Proteinuria (ZENITH High Proteinuria)
A Phase 3 study testing Zibotentan/Dapagliflozin and Dapagliflozin in people with Chronic Kidney Disease With High Proteinuria, run by AstraZeneca at 296 sites in 30 countries.
Trial summary
This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Chronic Kidney Disease With High Proteinuria
- What is being tested?
- Zibotentan/Dapagliflozin and Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,835 participants
- Where
- 296 sitesin 30 countries
- Study dates
- 7 Nov 2023to 18 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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).
- All female participants must have a negative serum pregnancy test result at screening.
- 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
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- Capable of giving signed informed consent
- Provision of signed informed consent prior to any study specific procedure.
- Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ).
- 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.
- Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.
Who cannot join
- Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
- Participants hospitalised for HF during the last 6 month prior to screening.
- Evidence of rales or jugular venous distention on physical examination.
- Participants with type 1 diabetes mellitus.
- History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
- Blood pressure above 160 mmHg systolic.
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- Blood pressure below 90 mmHg systolic.
- Participants hospitalised for heart disease or cardiac procedures or for COVID-19 during the last 3 months prior to screening.
- History of solid organ transplantation or bone marrow transplant.
- 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).
- Any condition with a life expectancy of less than 2 years based on investigator´s clinical judgment.
- Malignancy within the past 5 years. Exceptions to this criterion include non-melanoma skin cancer and curatively treated cervical carcinoma in situ.
- 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.
- Known blood-borne diseases.
- Clinically significant, unstable, or uncontrolled medical condition as assessed by the Investigator.
- Participants on renal replacement therapy or previous kidney transplant.
- Known history of drug or alcohol abuse within 12 months of screening.
- Participants on treatment with strong or moderate CYP3A4 inducer.
- 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.
- Participants treated or expecting to be treated with tolvaptan, any other ERAs, or budesonide (where used to treat IBD or IgAN).
- Participation in another clinical study with a study intervention administered in the last 3 months.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- 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.
- Previous randomisation in the present study.
- Women who are pregnant, breast-feeding, or women with intent of getting pregnant.
- 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.
Trial locations and contacts
296 sites in 30 countries.
296 sites in 30 countries
United States64 sites
Research Site
Albany, New York, 12205
Research Site
Alexandria, Virginia, 22311
Research Site
Arlington, Texas, 76015
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Arvada, Colorado, 80002
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Austin, Texas, 78726
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Bakersfield, California, 93309
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Bowling Green, Kentucky, 42101
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Boynton Beach, Florida, 33435
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Champaign, Illinois, 61822
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Chicago, Illinois, 60616
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City of Saint Peters, Missouri, 63376
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Denver, Colorado, 80230
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East Providence, Rhode Island, 02915
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Fayetteville, Georgia, 30214
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Flint, Michigan, 48504
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Flint, Michigan, 48532
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Greenville, North Carolina, 27834
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Hialeah, Florida, 33016
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Hinsdale, Illinois, 60521
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Hollywood, Florida, 33024
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Houston, Texas, 77004
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Houston, Texas, 77099
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Huntington Park, California, 90255
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Huntsville, Alabama, 35805
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Island Lake, Illinois, 60042
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Jacksonville, Florida, 32204
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Jacksonville, North Carolina, 28546
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Jensen Beach, Florida, 34957
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Kingsport, Tennessee, 37660
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Kinston, North Carolina, 28504
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Los Alamitos, California, 90720
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Los Angeles, California, 90010
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Maumee, Ohio, 43537
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Miami, Florida, 33126
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Miami, Florida, 33165
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Middletown, New York, 10940
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Mukilteo, Washington, 98275
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New Bern, North Carolina, 28562
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Newport News, Virginia, 23606
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Northridge, California, 91324
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Orchard Park, New York, 14127
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Orlando, Florida, 32806
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Oxnard, California, 93036
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Pearland, Texas, 77584
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Pottstown, Pennsylvania, 19464
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San Antonio, Texas, 78204
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San Antonio, Texas, 78207
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San Antonio, Texas, 78212
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San Carlos, California, 94070
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San Dimas, California, 91773
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Shreveport, Louisiana, 71101
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Silver Spring, Maryland, 20901
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Skokie, Illinois, 60077
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South Salt Lake, Utah, 84115
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Spokane, Washington, 99204
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Statesville, North Carolina, 28625
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Sugar Land, Texas, 77478
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Sun City West, Arizona, 85375
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Tarzana, California, 91356
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Troy, Michigan, 48098
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Victorville, California, 92392
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Wilmington, North Carolina, 28401
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Wilmington, North Carolina, 28412
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Winston-Salem, North Carolina, 27103
Japan38 sites
Research Site
Chūōku, 103-0027
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Fujisawa-shi, 251-0041
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Fukui-shi, 910-8526
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Fukuoka, 810-0001
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Fukuoka, 810-8563
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Fukuoka, 819-0168
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Hashima-gun, 501-6061
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Kamakura-shi, 247-0056
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Kasuga-shi, 816-0864
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Kawaguchi-shi, 332-0012
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Kitakyushu-shi, 802-8555
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Kitakyusyu-shi, 806-8501
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Kofu, 400-8506
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Kurume-shi, 830-0011
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Kurume-shi, 830-8543
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Kusatsu-shi, 525-8585
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Kyoto, 607-8062
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Matsumoto-shi, 390-8510
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Meguro-ku, 153-0061
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Minatoku, 108-0073
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Minokamo Shi, 505-8510
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Nishinomiya-shi, 662-0971
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Nishinomiya-shi, 663-8241
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Okawa-shi, 831-0016
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Osaka, 550-0006
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Osaka, 559-0012
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Oyama-shi, 323-0022
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Sakushu, 385-8558
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Sapporo, 003-0026
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Sapporo, 062-0931
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Sendai, 980-8574
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Soka-shi, 340-0015
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Takamatsu, 760-0076
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Takasago-shi, 676-0812
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Tondabayashi-shi, 584-0082
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Toride-shi, 302-0022
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Urayasu, 279-0001
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Utsunomiya, 320-8580
China33 sites
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Baotou, 014010
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Beijing, 100029
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Beijing, 102218
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Changsha, 410013
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Chengdu, 610000
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Chengdu, 610072
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Chongqing, 400010
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Deyang, 618000
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Foshan, 528000
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Guangzhou, 510120
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Guangzhou, 510515
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Hangzhou, 310014
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Hengyang, 421001
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Linhai, 317000
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Nanjing, 210009
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Nanjing, 210011
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Nanning, 530022
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Ningbo, 315010
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Pingxiang, 337055
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Shanghai, 200240
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Shantou, 515041
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Shenzhen, 518039
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Shenzhen, 518053
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Wenzhou, 325000
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Wuhan, 430010
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Wuxi, 214000
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Xi'an, 710061
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Xiamen, 361101
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Yantai, 264000
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Yibin, 610500
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Yinchuan, 750004
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Zhuzhou, 412007
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Zigong, 643000
Poland9 sites
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Chrzanów, 32-500
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Krakow, 31-156
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Krakow, 31-501
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Lodz, 92-213
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Poznan, 60-354
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Radom, 26-600
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Rzeszów, 35-055
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Szczecin, 70-111
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Warsaw, 03-291
Taiwan9 sites
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Kaohsiung City, 807
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Kaohsiung City, 833
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New Taipei City, 220
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Taichung, 407219
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Tainan, 710
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Taipei, 10002
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Taipei, 110
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Taipei, 11490
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Taoyuan, 333
France8 sites
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La Tronche, 38700
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Mulhouse, 68100
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Nice, 06000
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Nîmes, 30000
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Rouen, 76031
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Saint-Priest-en-Jarez, 42270
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Strasbourg, 67090
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Tours, 37000
Israel8 sites
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Ashkelon, 78278
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Haifa, 3109601
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Jerusalem, 9372212
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Kfar Saba, 44281
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Nahariya, 22100
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Petah Tikva, 49372
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Ramat Gan, 52621
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Rehovot, 76100
Italy8 sites
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Bergamo, 24127
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Bologna, 40138
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Foggia, 71100
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Genoa, 16132
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Naples, 80138
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Pisa, 56124
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Roma, 161
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Torino, 10126
South Korea8 sites
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Ansan-si, 15355
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Busan, 49241
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Cheonan-si, 31151
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Daegu, 41944
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Goyang-si, 10380
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Seoul, 06591
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Seoul, 120-752
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Seoul, 156-707
Brazil7 sites
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Belém, 66073-005
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Botucatu, 18618-687
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Joinville, 89227-680
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São José do Rio Preto, 15090-000
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São Paulo, 01228-200
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São Paulo, 04012-909
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São Paulo, 04038-031
Germany7 sites
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Aachen, 52074
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Bad Oeynhausen, 32545
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Berlin, 10117
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Dresden, 01279
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Hanover, 30625
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Mainz, 55131
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München, 80336
South Africa7 sites
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Benoni, 1501
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Cape Town, 7925
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Chatsworth, 4092
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Durban, 4450
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Lenasia, 1827
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Midrand, 1685
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Parow, 7505
Spain7 sites
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Girona, 17007
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L'Hospitalet de Llobregat, 08907
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Lugo, 27004
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Madrid, 28041
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Majadahonda, 28222
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Seville, 41071
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Valencia, 46010
Turkey (Türkiye)7 sites
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Adapazarı, 54100
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Ankara, 06230
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Bursa, 16059
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Dinar, 03400
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Kahramanmaraş, 46040
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Kayseri, 38039
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Kocaeli, 41380
United Kingdom7 sites
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Cardiff, CF14 4XW
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Dundee, DD1 9SY
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Glasgow, G51 4TF
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London, E1 1BB
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London, NW3 2QG
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London, SE5 9RJ
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York, YO21 8HE
Australia6 sites
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Gosford, 2250
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Meadowbrook, 4131
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Perth, 6000
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Reservoir, 3021
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Reservoir, 3073
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Southport, 4222
Bulgaria6 sites
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Dobrich, 9300
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Pleven, 5800
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Plovdiv, 4000
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Plovdiv, 4001
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Sofia, 1680
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Stara Zagora, 6000
Malaysia6 sites
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Alor Star, 5460
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Ipoh, 30990
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Kota Kinabalu, 88200
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Kuala Lumpur, 59100
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Seremban, 70300
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Seri Manjung, 32040
Thailand6 sites
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Bangkok, 10330
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Bangkok, 10700
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Chaingmai, 50200
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Hat Yai, 90110
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Khon Kaen, 40002
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Ratchathewi, 10400
Argentina5 sites
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Ciudad de Buenos Aires, 1280
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Ciudad de Buenos Aires, C1425AGC
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Mar del Plata, 7600
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Mar del Plata, B7600
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Santa Fe, S3000
Denmark5 sites
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Aalborg, 9100
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Aarhus, 8200
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Herlev, 2730
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Herning, 7400
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Roskilde, 4000
India5 sites
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Bangalore, 560060
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Belagavi, 590010
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Delhi, 110029
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Nadiād, 387001
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New Delhi, 110017
Norway5 sites
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Bodø, 8073
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Lørenskog, 1478
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Oslo, 0450
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Stavanger, 4011
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Tromsø, 9019
Slovakia5 sites
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Lučenec, 984 01
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Prešov, 080 01
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Púchov, 020 01
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Rožňava, 048 01
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Trebišov, 07501
Sweden5 sites
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Gothenburg, 413 46
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Linköping, 581 85
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Rättvik, 79530
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Stockholm, 141 86
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Uppsala, 751 85
Vietnam5 sites
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Haiphong, 180000
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Hanoi, 10000
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Ho Chi Minh City, 700000
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Ho Chi Minh City, 70000
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Ho Chi Minh City
Canada4 sites
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Greenfield Park, Quebec, J4V 2H1
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London, Ontario, N6A 5A5
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Montreal, Quebec, H4J 1C5
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Waterloo, Ontario, N2T 0C1
Netherlands3 sites
Research Site
Amersfoort, 3813 TZ
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Breda, 4818 CK
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Dordrecht, 3318 AT
About this study
Official title: A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria
This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria
- Being tested
- Zibotentan/Dapagliflozin, Dapagliflozin
- Keywords
- Zibotentan, Nephrology, Dapagliflozin, Sodium-glucose co-transporter 2, sodium-glucose co-transporter 2 inhibitor, Kidney diseases, Endothelin antagonist, High Proteinuria
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zibotentan/DapagliflozinDrug
Participants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to
DapagliflozinDrug
Participants will receive dapagliflozin as per the arms they are randomized to
| Study group | Role | What they receive |
|---|---|---|
| Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B | Experimental | Drug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination. Receives: Drug: Zibotentan/Dapagliflozin |
| Dapagliflozin alone | Active comparator | Participants will receive daily oral dose of dapagliflozin. Receives: Drug: Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eGFR from baseline
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone to slow decline in kidney function
Measured: At month 24
Secondary outcomes (3)
Change in Urine Albumin to Creatinine Ratio (UACR) from baseline
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing albuminuria
Measured: at Month 9
Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone in reducing the incidence of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
Measured: Through study completion, approximately 38 months
Change in Urine Protein to Creatinine Ratio (UPCR) from baseline
To determine whether zibotentan and dapagliflozin in FDC is superior to dapagliflozin alone in reducing proteinuria in the biopsy-confirmed IgAN subgroup
Measured: at Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start7 Nov 2023
- Primary completion18 Feb 2027 (estimated)
- Study completion18 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease With High ProteinuriaStudies 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
- 1,835 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087835
- Sponsor's protocol ID
- D4325C00010
- Other IDs
- 2023-504124-26, 2023
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- 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 requests 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.
Publications
Muhammad Daniyal S, Ajaz H, Riaz M, Murad Khatoon N, Aftab Z, Tauqir Gondal H, Gul I, Sarwar M, Batool F, Fahim SL, Noor A, Khalid A, Ashraf DA, Jabarkhil R. Combination therapy with mineralocorticoid receptor antagonists and SGLT2 inhibitors versus SGLT2 inhibitor monotherapy in chronic kidney disease: an updated meta-analysis of randomized controlled trials. BMC Nephrol. 2025 Dec 22;27(1):69. doi: 10.1186/s12882-025-04710-2.
PubMed 41430169Smeijer JD, Wasehuus VS, Dhaun N, Gorriz JL, Soler MJ, Astrand M, Mercier AK, Greasley PJ, Ambery P, Heerspink HJL. Effects of Zibotentan Alone and in Combination with Dapagliflozin on Fluid Retention in Patients with CKD. J Am Soc Nephrol. 2024 Oct 1;35(10):1381-1390. doi: 10.1681/ASN.0000000000000436. Epub 2024 Jul 12.
PubMed 39352861
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomised, Multicentre, Double-blind Study to Evaluate the Efficacy, Safety, and Tolerability of Zibotentan/Dapagliflozin Compared to Dapagliflozin Alone in Participants With Chronic Kidney Disease and High Proteinuria
- ClinicalTrials.gov ID
- NCT06087835
- Acronym / sponsor ID
- D4325C00010
- Keywords
- Zibotentan, Nephrology, Dapagliflozin, Sodium-glucose co-transporter 2, sodium-glucose co-transporter 2 inhibitor, Kidney diseases, Endothelin antagonist, High Proteinuria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,835 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 18 Feb 2027 (estimated)
- Study completion
- 18 Feb 2027 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III, randomised, multicentre, double-blinded study to evaluate efficacy, safety and tolerability of treatment with zibotentan/dapagliflozin and dapagliflozin alone in participants with chronic kidney disease (CKD) and high proteinuria
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B | Experimental | Drug: Zibotentan/DapagliflozinDrug dose (dose A or B) are determined based on eGFR values. Participants will receive daily oral dose of zibotentan/dapagliflozin in fixed dose combination. |
| Dapagliflozin alone | Active comparator | Drug: DapagliflozinParticipants will receive daily oral dose of dapagliflozin. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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).
- All female participants must have a negative serum pregnancy test result at screening.
- Female participants must be either
- Capable of giving signed informed consent
Key exclusion criteria (26 listed)
- Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
- Participants hospitalised for HF during the last 6 month prior to screening.
- Evidence of rales or jugular venous distention on physical examination.
- Participants with type 1 diabetes mellitus.
- History of any life-threatening ventricular dysrhythmia (continuous or paroxysmal).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zibotentan/DapagliflozinParticipants will receive zibotentan/dapagliflozin in fixed-dose combination as per the arms they are randomized to | Drug | Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B |
| DapagliflozinParticipants will receive dapagliflozin as per the arms they are randomized to | Drug | Dapagliflozin alone |
Primary outcome
Change in eGFR from baseline
Time frame: At month 24
To determine whether zibotentan and dapagliflozin in fixed dose combination is superior to dapagliflozin alone to slow decline in kidney function
3 secondary outcomes
Change in Urine Albumin to Creatinine Ratio (UACR) from baseline
Time frame: at Month 9
Time to the first occurrence of any of the components of the renal composite endpoint of 40% sustained decline in eGFR or ESKD or renal death
Time frame: Through study completion, approximately 38 months
Change in Urine Protein to Creatinine Ratio (UPCR) from baseline
Time frame: at Month 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 41430169Muhammad Daniyal S, Ajaz H, Riaz M, Murad Khatoon N, Aftab Z, Tauqir Gondal H, Gul I, Sarwar M, Batool F, Fahim SL, Noor A, Khalid A, Ashraf DA, Jabarkhil R. Combination therapy with mineralocorticoid receptor antagonists and SGLT2 inhibitors versus SGLT2 inhibitor monotherapy in chronic kidney disease: an updated meta-analysis of randomized controlled trials. BMC Nephrol. 2025 Dec 22;27(1):69. doi: 10.1186/s12882-025-04710-2.
- Derived from this study: PubMed 39352861Smeijer JD, Wasehuus VS, Dhaun N, Gorriz JL, Soler MJ, Astrand M, Mercier AK, Greasley PJ, Ambery P, Heerspink HJL. Effects of Zibotentan Alone and in Combination with Dapagliflozin on Fluid Retention in Patients with CKD. J Am Soc Nephrol. 2024 Oct 1;35(10):1381-1390. doi: 10.1681/ASN.0000000000000436. Epub 2024 Jul 12.
- Individual participant dataSharing planned: 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 requests 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.
Related trials for Chronic Kidney Disease With High Proteinuria
Active, not recruitingPhase 2
A Study to Investigate the Effects of Zibotentan/Dapagliflozin Combination Compared to Dapagliflozin Alone in Adult Participants With Chronic Kidney Disease and High Proteinuria
Chronic Kidney Disease With High Proteinuria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
296 sites in 30 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zibotentan/Dapagliflozin and Dapagliflozin in people with Chronic Kidney Disease With High Proteinuria, run by AstraZeneca at 296 sites in 30 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 296 sites in United States, Japan, China, Poland, Taiwan and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eGFR from baseline (time frame: At month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06087835, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.