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) (NCT06087835)

🧪 Interventions in This Study

• Zibotentan/Dapagliflozin (DRUG)
• Dapagliflozin (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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
5. not of child-bearing potential or
6. 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
7. Capable of giving signed informed consent
8. Provision of signed informed consent prior to any study specific procedure.
9. Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ).
10. 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.
11. Receiving RAASi therapy (ACEi or ARB), and for the patient maximum tolerated labelled daily dose, that has been stable for at least 4 weeks.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (296 Sites)

Showing the first 25 of 296 sites.

• Research Site — Huntsville, Alabama
• Research Site — Sun City West, Arizona
• Research Site — Bakersfield, California
• Research Site — Huntington Park, California
• Research Site — Los Alamitos, California
• Research Site — Los Angeles, California
• Research Site — Northridge, California
• Research Site — Oxnard, California
• Research Site — San Carlos, California
• Research Site — San Dimas, California
• Research Site — Tarzana, California
• Research Site — Victorville, California
• Research Site — Arvada, Colorado
• Research Site — Denver, Colorado
• Research Site — Boynton Beach, Florida
• Research Site — Hialeah, Florida
• Research Site — Hollywood, Florida
• Research Site — Jacksonville, Florida
• Research Site — Jensen Beach, Florida
• Research Site — Miami, Florida
• Research Site — Miami, Florida
• Research Site — Orlando, Florida
• Research Site — Fayetteville, Georgia
• Research Site — Champaign, Illinois
• Research Site — Chicago, Illinois

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Chronic Kidney Disease With High Proteinuria clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.