Metformin as RenoProtector of Progressive Kidney Disease

Sponsor
Universiteit Antwerpen
Study ID
NCT03831464
Phase
PHASE3
Status
Unknown

Conditions

  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride — DRUG
    The intervention will consist in IMP treatment during 30 months with half of the patients treated with Metformin Glucophage SR. Tablets of 500mg will be used at a dose of 2x500mg preferably taken during the evening meal. During the first month of the trial a dose of 1x500mg will be used in order to avoid as much as possible some well-known mainly gastrointestinal side effects of metformin treatment .
  • Placebo Oral Tablet — DRUG
    The intervention will consist in IMP treatment during 30 months with half of the patients treated with matched placebo. Tablets of 500mg will be used at a dose of 2x500mg preferably taken during the evening meal.

Study Details

A multi-center, practice-oriented, repurposing, double-blinded, placebo-controlled, randomized clinical trial. The RenoMet trial is repurposing an already approved agent (Metformin , Glucophage SR ) in a new indication (renoprotection ) in a new class of patients (chronic kidney disease patients CKD 2, 3A, 3B and including patients with renal transplant for more than 3 years).

Key Dates

Start date
Nov 5, 2019
Status verified
Dec 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
290 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Metformin treatment group
  • Placebo Comparator: Placebo control group

Primary Outcome Measure

Reaching a 30% decline of eGFR [ Time Frame: Period of 30 months ]

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