Metformin as RenoProtector of Progressive Kidney Disease

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 385

Inclusion Criteria

Patients will be eligible for inclusion in the RenoMet study based on the following inclusion criteria:
- Adult patients (18-75 years) of both gender
- Seen on a regular base in one of the participating outpatient clinics of renal care with a previous consultation within the last year
- Having a chronic kidney disease with:
- A CKD stage 2, 3A or 3B ( i.e. with estimated glomerular filtration rate (eGFR) between 30 and 90 ml/min/1.73m2) at the time of the baseline visit
- Without proteinuria or with proteinuria below or equal to 2 g/24hrs
- Showing a decline of eGFR between 2.0 and 15.0 ml/min/year determined using at least three determinations of eGFR (CKD-Epi formula) within the last three years before inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 289
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96

Exclusion Criteria

Patients will be excluded from study participation based on the following exclusion criteria:
1. Illiteracy: patients not knowing how to read or write
2. Patients not able to communicate in Dutch or French
3. Patients with mental deterioration, incapable to give informed consent and to understand the safety instructions of the study (at the discretion of the treating nephrologist)
4. Patients with one of the following clinical problems:
- Patients with overt proteinuria (more than 2 g/24hrs)
- Patients showing a fast decline of renal function (more than 15 ml/min/year) during the preceding three years
- Diabetes mellitus (any type: 1, 2, maturity onset diabetes of the young (MODY)…) confirmed by a glycemia level > 126 mg/L (7.0 mmol/L) after a fasting time of 8 hours
- Chronic obstructive pulmonary disease ( COPD) stage Gold IV (Oxygene-dependency)
- Congestive heart failure (NYHA stage IV)
- Inflammatory bowel disease (IBD)
- Stoma
- Hepatic insufficiency or cirrhosis, acute alcohol intoxication or alcoholism (> 20 glasses of alcoholic beverages per week)
- History of solid organ transplantation
- History of metabolic diseases (e.g. mitochondrial encephalomyopathy (MELAS), lactic acidosis, stroke-like episodes, etc…)
- Pregnancy and/or lactating women at the time of recruitment and during the study period
5. Patient with one of the following medication:
- Prior use of metformin within the past 12 months (e.g. glucose intolerance, polycystic ovary syndrome, etc…)
- Chronic use of CNI (calcineurine inhibitors) (e.g. psoriasis...)
6. Patients showing elevated serum lactate level(s) at the time of recruitment ( i.e. a serum lactate level >2.5 mmol/L at baseline visit or a confirmed serum lactate level > 2.0 mmol/L within a period of 4 weeks)
7. Hypersensitivity to metformin or to any of the excipients listed in section 6.1 of the Glucophage SR SmPC (see Attachment A5 Glucophage SR SmPC)
8. One of the following diseases during the previous 6 months: myocardial infarction, shock, acute problems of decompensated heart failure or respiratory failure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: To show that chronic renal failure patients treated with Metformin compared to patients treated with placebo will have (1) lower mortality, (2) slower decrease of their renal function, (3) less development of end-stage renal disease, (4) less co-morbidity, (5) lower hospitalization rate, (6) improved quality of life, (7) limited adverse drug reactions;Primary end point(s): Time to event of reaching a 30% decline of eGFR over the investigation period of 30 months in the intervention group compared to the control group, expressed as a hazard ratio in a time-to-event analysis.;Timepoint(s) of evaluation of this end point: Period of 30 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Incidence of mortality, development of end-stage renal disease, specific co-morbidities and hospitalization<br>•Evolution of the renal function <br>•Quality of life <br>•Adverse drug reactions ;Timepoint(s) of evaluation of this end point: Period of 30 months

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