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SGLT2 Inhibitor

Zibotentan + Dapagliflozin for Kidney Disease (ZODIAC Trial)

Phase 2
Waitlist Available
Led By Hiddo J Lambers Heerspink, PhD, PharmD
Research Sponsored by University Medical Center Groningen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 and ≤75 years
eGFR ≥ 30 mL/min/1.73m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

ZODIAC Trial Summary

This trial will test if two drugs given together can help reduce albuminuria (a protein in urine) more than either drug given alone.

Who is the study for?
Adults aged 18-75 with type 2 diabetes, HbA1c ≥6.0%, and kidney issues shown by high albumin in urine can join this trial. They must be on stable heart medication for a month and not have type 1 diabetes, severe non-diabetic kidney disease, very high blood sugar, or conditions like heart failure that could risk their safety or affect results.Check my eligibility
What is being tested?
The study tests if Zibotentan (a drug blocking certain receptors) combined with Dapagliflozin (a drug reducing sugar absorption in kidneys) better reduces protein leakage into urine than either alone without causing fluid retention. Participants will randomly receive one of the drugs alone, both together, or a placebo.See study design
What are the potential side effects?
Possible side effects include fluid retention leading to swelling (especially with Zibotentan), low blood pressure, dizziness when standing up due to dehydration risks from Dapagliflozin, urinary tract infections, and potential allergic reactions.

ZODIAC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My kidney function is at a safe level for the trial.
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I have been diagnosed with type 2 diabetes.

ZODIAC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks 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 from baseline in albuminuria after 4 weeks combined zibotentan and dapagliflozin treatment versus four weeks treatment with zibotentan alone.
Secondary outcome measures
Body Weight Changes
Change in Extracellular Fluid
Change in Extracellular volume (ECV)
+5 more
Other outcome measures
Change in copeptin
Aldosterone

ZODIAC Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment order 2Experimental Treatment4 Interventions
Subjects will start with 4 weeks of dapagliflozine in treatment period one, then 4 weeks of zibotentan during treatment period two. The order of the first two treatment periods is random which means that patients can start with either dapagliflozine or zibotentan. Then in treatment period three, patients are randomized to either either placebo or dapagliflozin for 2 weeks followed immediately by 4 weeks of both zibotentan and dapagliflozin. Between treatment periods there is a 4-week wash-out.
Group II: Treatment order 1Experimental Treatment4 Interventions
Subjects will start with 4 weeks of placebo in treatment period one, then 4 weeks of zibotentan during treatment period two. The order of the first two treatment periods is random which means that patients can start with either placebo or zibotentan. Then in treatment period three, patients are randomized to either either placebo or dapagliflozin for 2 weeks followed immediately by 4 weeks of both zibotentan and dapagliflozin. Between treatment periods there is a 4-week wash-out.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zibotentan
2019
Completed Phase 2
~810
Dapagliflozin
2014
Completed Phase 4
~64880
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

University Medical Center GroningenLead Sponsor
711 Previous Clinical Trials
976,759 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,259 Previous Clinical Trials
288,593,864 Total Patients Enrolled
Hiddo J Lambers Heerspink, PhD, PharmDPrincipal InvestigatorUniversity Medical Center Groningen
1 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

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

Are individuals of all ages being accepted for this study?

"This trial is open to patients aged 18-75. There are 43 similar trials for minors and 479 for seniors."

Answered by AI

Might I be eligible to take part in this experiment?

"Up to 38 patients that have been diagnosed with chronic kidney disease (CKD) and meet the following additional requirements can participate in this clinical trial: age between 18-75 years old, a diagnosis of type 2 diabetes, Hba1c score above 6.0%, urinary albumin:creatinine ratio no more than 3500 mg/g in a first morning void urine collection, eGFR must be 30 mL/min/1.73m2 or higher, ACEi or ARB stable dose for at least 4 weeks before randomization, and being willing to sign informed consent."

Answered by AI

Are we still enrolling patients for this clinical trial?

"Unfortunately, this particular study is no longer looking for patients to enroll. According to the information available on clinicaltrials.gov, recruitment for this trial ceased on October 18th, 2022; although there are 519 other trials currently recruiting individuals."

Answered by AI

Are there any negative side effects associated with Treatment order 1?

"While efficacy has not been proven, there is evidence that suggests treatment order 1 is safe. We've given it a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria
Hiddo Lambers Heerspink 2022. "Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05570305.
~15 spots leftby Apr 2025
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