Zibotentan + Dapagliflozin for Chronic Kidney Disease

Recruiting in Palo Alto (17 mi)

+228 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing two treatments for people with chronic kidney disease who have high levels of protein in their urine. One treatment combines two drugs, zibotentan and dapagliflozin, while the other uses only dapagliflozin. Zibotentan helps relax blood vessels to reduce kidney damage, and dapagliflozin lowers blood sugar and protects the kidneys.

Eligibility Criteria

Adults with chronic kidney disease and high protein in urine, on stable RAASi therapy for at least 4 weeks. They must not have severe heart conditions, recent hospitalizations for heart issues or COVID-19, organ transplants, certain cancers within the last 5 years, drug/alcohol abuse history within a year, or be on specific other treatments.

Inclusion Criteria

I have chronic kidney disease with specific kidney function and protein levels.

I am not pregnant, as confirmed by a blood test.

Exclusion Criteria

I was hospitalized for heart failure in the last 6 months.

I have severe heart failure.

I have type 1 diabetes.

I am on dialysis or have had a kidney transplant.

I have signs of fluid in my lungs or swollen neck veins.

I have had dangerous irregular heartbeats.

I have been hospitalized for heart issues or COVID-19 in the last 3 months.

I have had a solid organ or bone marrow transplant.

I am currently taking medication that strongly affects liver enzymes.

Participant Groups

The trial is testing the effectiveness of Zibotentan combined with Dapagliflozin versus Dapagliflozin alone in patients with chronic kidney disease to see which is better at managing their condition. It's a Phase III study where participants are randomly assigned to one of these two options.

2Treatment groups

Experimental Treatment

Active Control

Group I: Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose BExperimental Treatment1 Intervention

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.

Group II: Dapagliflozin aloneActive Control1 Intervention

Participants will receive daily oral dose of dapagliflozin.

Dapagliflozin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Forxiga for: