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A Phase III Study to assess efficacy, safety, and tolerability of Zibotentan combined with Dapagliflozin, compared to Dapagliflozin, in patients with Chronic Kidney Disease and High Proteinuria
EU CTIS ID: 2023-504124-26-00
What this study is testing
To determine whether zibotentan and dapagliflozin in fixed-dose combination is superior to dapagliflozin alone to slow decline in kidney function
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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, with eGFR ≥ 20 and < 90 mL/min/1.73 m2 and UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113mg/mmoL).
- 3.All female participants must have a negative serum pregnancy test result at screening (unless participants meet inclusion criterion 4a for being of not childbearing potential.)
- 4. Female participants must be either - not of child-bearing potential or - 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.
You likely can't join if
- 1.Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
- 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) or any of the excipients of the products.
- 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.
See the full eligibility criteria
Who can join
- 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, with eGFR ≥ 20 and < 90 mL/min/1.73 m2 and UACR > 700 mg/g (> 79 mg/mmol) or UPCR > 1000 mg/g (> 113mg/mmoL).
- 3.All female participants must have a negative serum pregnancy test result at screening (unless participants meet inclusion criterion 4a for being of not childbearing potential.)
- 4. Female participants must be either - not of child-bearing potential or - 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 5.
- 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.
What rules you out
- 1.Participants with NYHA class III or class IV Congestive HF at the time of enrolment.
- 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) or any of the excipients of the products.
- 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.
- 2. Participants hospitalised for HF during the last 6 month prior to screening.
- 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.
- 3. Evidence of rales or jugular venous distention on physical examination
- 4. Participants with T1DM.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico
- India
- Malaysia
- Thailand
- China
- Argentina
- Vietnam
- Japan
- Brazil
- Turkey
- Australia
- Taiwan
- Canada
- United Kingdom
- Israel
- United States
- South Africa
- Philippines
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico; India; Malaysia; Thailand; China; Argentina and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.