Zibotentan and Dapagliflozin in Patients With Type 2 Diabetes and Elevated Albuminuria

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Kidney Diseases

In brief

The aim of this study is to test the hypothesis that the effects on albuminuria of combination treatment with the endothelin receptor antagonist zibotentan and SGLT2i dapagliflozin are complimentary and additive while the fluid retaining effects of zibotentan can be mitigated by dapagliflozin.

Key facts

Study ID: NCT05570305
Run by: University Medical Center Groningen
People needed: 42
Starts: 2022-10-06
Expected to finish: 2025-03-05
Last updated by the study team: 2025-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥18 and ≤75 years
Urinary albumin:creatinine ratio > 100 mg/g and ≤ 3500 mg/g in a first morning void urine collection
eGFR ≥ 30 mL/min/1.73m2
On a stable dose of an ACEi or ARB for at least 4 weeks prior to randomization
Willing to sign informed consent

You may not qualify if…

Diagnosis of type 1 diabetes
Minimal change disease, unstable rapidly progressing renal disease, and/or renal disease requiring significant immunosuppression, autosomal dominant or autosomal recessive polycystic kidney disease
Hba1c > 12.5%
Urinary protein excretion > 3500 mg/day
Heart Failure NYHA Class III or IV
NT-proBNP > 600 pg/ml
Hemoglobin <9g/dL
Acute coronary syndrome event within the preceding 6 months
Severe peripheral edema according to investigators opinion
Women of childbearing potential (WOCBP). WOCBP is defined as women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who are not post-menopausal
Pregnancy or breastfeeding
Indication for immunosuppressants according to Investigator's opinion
Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin within the last 5 years.
Use of the co-interventional treatments (outlined in section 5.2) within 6 weeks of screening.
Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
History of active inflammatory bowel disease within the last six months;
Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
Pancreatic injury or pancreatitis within the last six months;
Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
Evidence of urinary obstruction or difficulty in voiding at screening
Severe hepatic impairment
History of epilepsy syndrome
History of severe hypersensitivity or contraindications to dapagliflozin
History of hypersensitivity or contraindications to iodinated contrast media

Where it is running

Anschutz Medical Campus — Aurora, Colorado, United States
Toronto General Hospital — Toronto, Ontario, Canada
Montreal Clinical Research Institute — Montreal, Quebec, Canada
Steno Diabetes Center — Copenhagen, Gentoft, Denmark
Amsterdam Universitair Academisch Centrum — Amsterdam, North Holland, Netherlands
University Medical Center Groningen — Groningen, Netherlands
Center for Cardiovascular Science — Edinburgh, United Kingdom

Full record on ClinicalTrials.gov

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