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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
Must not have
History of severe hypersensitivity or contraindications to dapagliflozin
Evidence of urinary obstruction or difficulty in voiding at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Summary

This trial tests if combining zibotentan and dapagliflozin can better manage kidney damage in adults with type 2 diabetes. Zibotentan reduces harmful proteins in urine, and dapagliflozin lowers blood sugar and reduces fluid retention. Dapagliflozin is used to treat type 2 diabetes, heart failure, and chronic kidney disease by reducing blood glucose levels.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am severely allergic to dapagliflozin.
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I have trouble urinating or feel blocked.
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I have severe liver problems.
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My heart condition severely limits my daily activities.
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I have not lost or donated more than 400 ml of blood in the last 8 weeks.
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I have been diagnosed with type 1 diabetes.
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My kidney issues causing protein in my urine are not due to diabetes.
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I have been diagnosed with an epilepsy syndrome.
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I am a woman who can still have children and have not been sterilized or reached menopause.
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I have not had any cancer except for skin cancer in the last 5 years.
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I have had major surgery on my stomach or intestines.
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I haven't had stomach ulcers or bleeding in the last 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in albuminuria after 4 weeks combined zibotentan and dapagliflozin treatment versus four weeks treatment with zibotentan alone.
Secondary study objectives
Body Weight Changes
Change in Extracellular Fluid
Change in Extracellular volume (ECV)
+5 more
Other study objectives
Change in copeptin
Aldosterone

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
Placebo
1995
Completed Phase 3
~2670
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

University Medical Center GroningenLead Sponsor
740 Previous Clinical Trials
1,028,526 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,771 Total Patients Enrolled
Hiddo J Lambers Heerspink, PhD, PharmDPrincipal InvestigatorUniversity Medical Center Groningen
1 Previous Clinical Trials
36 Total Patients Enrolled
~13 spots leftby Sep 2025
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