MedTrace Logo

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

NCT05570305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Diseases

Interventions

DRUG

Zibotentan

Zibotentan 1.5 mg once per day as a hard capsule.

DRUG

Dapagliflozin

Dapagliflozin 10 mg once per day as a tablet.

DRUG

Placebo

Matching placebo.

DRUG

Dapagliflozin and Zibotentan

Dapagliflozin 10 mg once per day as a tablet in combination with zibotentan 1.5 mg once per day as a hard capsule.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Hiddo J Lambers Heerspink, PhD, PharmD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2025-03-05
Completion
2025-03-05
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05570305 on ClinicalTrials.gov