KCE-17006: Multizentrische, randomisierte, doppelblinde klinische Studie über die Schutzwirkung von Metformin auf die Nierenfunktion bei nicht-diabetischen Patienten mit frühem bis mittlerem Nierenversagen - RenoMet-Studie

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

 

Trial Description
Title

Metformin as RenoProtector in Non-Diabetic Patients with Progressive Chronic Kidney Disease (CKD stages 2, 3A and 3B): a multi-centre, practice-oriented, repurposing, double-blind,   placebo-controlled, randomized clinical trial  (RenoMet)

Participants (P)

Adult patients (≥18 years) of both gender,  with chronic kidney disease (CKD stage 2, 3A or 3B, i. e. with estimated glomerular filtration rate (eGFR) between 30 and 90 ml/min/1.73m2), without and with proteinuria (<= 2.0 g/24hrs) and showing a decline of eGFR between 2.0 and 15.0 ml/min/year are eligible for inclusion. Patients will be recruited in one of the 14-16 participating Belgian renal care clinics where they have regular follow-up visits for their chronic renal failure. CKD patients with diabetes will be excluded. Also CKD patients with overt proteinuria (more than 2 g/24hrs) and patients showing a fast decline of renal function (more than 15 ml/min/year during the preceding two years) will be excluded. Additionally, all contraindications as per Glucophage SR SmPC including hypersensitivity to metformin and the respective tablet excipients will be considered as exclusion criteria

Intervention (I)

Metformin

Control (C)

Placebo

Outcome (O)

To demonstrate that a Metformin dose of 1000 mg/day, can effectively and safely slow the progression of renal failure in non-diabetic patients with chronic renal failure stages CKD 2, CKD3A and 3B

Trial Design

A multi-centre, 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) 

Sample Size

We plan to include 385 patients (193 in the metformin treatment group, 192 in the matched placebo control group)

Trial duration

42 months

Budget

€ 2 724 656,70 (VAT included)

Status

Open to recruitment

 

Trial team

Sponsor

University of Antwerpen

Chief Investigator

Prof. Dr. Marc De Broe

University of Antwerpen

Trial coordinator

Monique Elseviers

University of Antwerpen

Sites - GPs

16 sites

External Partners

Universitair Ziekenhuis Antwerpen (UZA)

Dokumente
Protocol  
Report

Q1 2023

Publication

 

REFERENZEN

Clinicaltrials.gov: NCT03831464

Webpage: 

FINANZIERUNGSSCHEMA

Investigator-led workstream 2017