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Zibotentan + Dapagliflozin for Chronic Kidney Disease

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 43 months
Awards & highlights

Study Summary

This trial tests whether two medications can help people with CKD and excess protein in their urine.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include blood pressure changes, symptoms related to heart failure (like swelling), liver issues (elevated enzymes), sensitivity reactions to medication components and potential risks associated with diabetes medications such as dehydration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic kidney disease with specific kidney function and protein levels.
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I am not pregnant, as confirmed by a blood test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 43 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 43 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in eGFR from baseline
Secondary outcome measures
Change in UACR from baseline to each participant's mean level
Change in Urine Protein to Creatinine Ratio (UPCR) from baseline to each participant's mean level
Change in systolic blood pressure from baseline to each participant's mean level
+2 more

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Trial Design

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.

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,611,203 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participant is ideal for this research endeavor?

"To qualify for this clinical trial, a person must have chronic kidney disease and an age between 18 to 95 years old. This research endeavour is looking to recruit 1500 individuals in total."

Answered by AI

Does this research encompass individuals who are over 25 years old?

"The eligibility criteria for this experiment requires that participants are between the age of 18 to 95. Separately, there is a pool of 48 trials available for individuals younger than 18 and another composed of 495 open studies targeting seniors beyond 65 years old."

Answered by AI

What level of risk is associated with administering Zibotentan/Dapagliflozin dose A and B?

"The Zibotentan/Dapagliflozin dose A or B combination has been given a safety rating of 3 by Power, due to the data gathered in its Phase 3 trial showing positive efficacy results and multiple rounds of evidence for its overall security."

Answered by AI

How many venues can participants access this research endeavor?

"At present, the clinical trial is taking place in 95 sites located across Chatsworth, South Gate and Tarzana among others. It will be most beneficial to choose a site close by so that you do not have to travel too much when participating."

Answered by AI

Are there any vacancies to receive the experimental treatment within this trial?

"As per clinicaltrials.gov, this study is not presently enrolling participants. The trial was first posted on November 10th 2023 and the last update was made on October 17th 2023. Nevertheless, there are currently 537 other medical trials actively looking for patients to join their research projects."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
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)
2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087835.
All > Chronic Kidney Disease > Spokane
~1000 spots leftby Jun 2027
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