Effects of Dapagliflozin in Non-diabetic Patients With Proteinuria

Sponsor
Hiddo Lambers Heerspink
Study ID
NCT03190694
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Kidney Diseases
  • Proteinuria

Eligibility Criteria

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

Interventions

Study Details

This study tests the hypothesis that dapagliflozin lowers proteinuria in patients with non-diabetic chronic kidney disease.

Key Dates

Start date
Nov 12, 2017
Status verified
Jan 2024
Primary completion
Nov 1, 2019
Completion
Dec 1, 2019

Study Design

Enrollment
53 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin 10mg Tablet, then Placebo
    Participants first received Dapagliflozin 10mg tablet for 6 weeks. After a washout period of 6 weeks, they then received Placebo tablet for 6 weeks (matching Dapagliflozin 10mg). Dapagliflozin 10 mg: Green, plain, diamond shaped, film coated tablet (orally) Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingredient
  • Placebo Comparator: Placebo, then Dapagliflozin
    Participants first received Placebo tablet for 6 weeks. After a washout period of 6 weeks, they then received Dapagliflozin 10mg tablet for 6 weeks (matching Dapagliflozin 10mg). Placebo: Green, plain, diamond shaped, film coated tablet. Does not contain active ingrediënt Dapagliflozin 10 mg: Green, plain, diamond shaped, film coated tablet (orally)

Primary Outcome Measure

Change in 24-hr Proteinuria With Dapagliflozin for Six Weeks Relative to Placebo in Patients With Non-diabetic Kidney Disease and Proteinuria 500 mg/Day on Stable Angiotensin-converting Enzyme Inhibitor or Angiotensin II Receptor Blocker Treatment. [ Time Frame: 6 weeks ]

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