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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University Medical Center Groningen
Study ID
NCT05570305
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Zibotentan — DRUG
    Zibotentan 1.5 mg once per day as a hard capsule.
  • Dapagliflozin — DRUG
    Dapagliflozin 10 mg once per day as a tablet.
  • Placebo — DRUG
    Matching placebo.
  • Dapagliflozin and Zibotentan — DRUG
    Dapagliflozin 10 mg once per day as a tablet in combination with zibotentan 1.5 mg once per day as a hard capsule.

Study Details

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 Dates

Start date
Oct 6, 2022
Status verified
Apr 2025
Primary completion
Mar 5, 2025
Completion
Mar 5, 2025

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment order 1
    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.
  • Experimental: Treatment order 2
    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.

Primary Outcome Measure

Change from baseline in albuminuria after 4 weeks combined zibotentan and dapagliflozin treatment versus four weeks treatment with zibotentan alone. [ Time Frame: The albuminuria will be measured before start of medication intake and after the last intake of medication for each treatment period. This concerns a 4 week time frame. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Anschutz Medical CampusAuroraColorado80045-

Find similar trials in Aurora, CO

By research site
Anschutz Medical Campus· Aurora, CO

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