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.

Research Team

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

Provision of electronic informed consent prior to completion of the optional Study Participant Feedback Questionnaire (SPFQ).

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

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

Exclusion Criteria

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

I have severe heart failure.

Your doctor believes you have less than 2 years to live due to a health condition.

Treatment Details

Interventions

• Dapagliflozin (Other)
• Zibotentan/Dapagliflozin (Other)

Trial Overview 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.

Participant Groups

Group I: Zibotentan/Dapagliflozin dose A or Zibotentan/Dapagliflozin dose B Experimental Treatment 1 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 alone Active Control 1 Intervention

Participants will receive daily oral dose of dapagliflozin.

Dapagliflozin is already approved in Canada for the following indications:

Approved in Canada as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology