Status:
UNKNOWN
Metformin as RenoProtector of Progressive Kidney Disease
Lead Sponsor:
Universiteit Antwerpen
Collaborating Sponsors:
University Hospital, Antwerp
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ) i...
Detailed Description
The intervention consists in the treatment of patients with progressive kidney disease and blindly randomized to the treatment group with metformin as medication, added to their usual treatment. Metfo...
Eligibility Criteria
Inclusion
- Adult patients (≥18 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 (including having a transplant kidney for more than 3 years) with:
- a CKD stage 2, 3A or 3B (i.e. with estimated glomerular filtration rate (eGFR) between 30 and 70 ml/min/1.73m2) at the time of the baseline visit
- showing a decline of eGFR between 3.0 and 20.0 ml/min/year determined using at least three determinations of eGFR (CKD-Epi formula) whereby the oldest one should be from more than 1 year ago and the most recent will be the one of the baseline visit. For transplant patients the decline will be based on serum creatinine values determined during the preceding 24 months. For all other patients, the decline will be based on values determined within the last five years
Exclusion
- Illiteracy: patients not knowing how to read or write
- Patients not able to communicate in Dutch or French
- 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)
- Patients with one of the following clinical problems:
- Patients with nephrotic syndrome
- Patients showing a fast decline of renal function (more than 20 ml/min/year) during the preceding five years
- Diabetes mellitus (any type: 1, 2, Maturity Onset Diabetes of the Young (MODY), New Onset Diabetes After Transplantation (NODAT)) confirmed by a glycemia level \>125 mg/dl (7.0 mmol/L) after a fasting time of 8 hours
- Patients with a renal transplantation for less than 3 years
- Patients with multi-organ transplantation
- History of other solid organ transplantations
- 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 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
- Patient with prior use of metformin within the past 12 months (e.g. glucose intolerance, polycystic ovary syndrome, etc…) or with other study medication taken within the framework of another clinical trial
- Patients showing elevated blood lactate level(s) at the time of recruitment (i.e. a confirmed lactate level ≥ 2.5 mmol/L at baseline and a confirmed lactate level ≥ 2.5 mmol/L after 4 weeks (±1 week)).
- Patients showing a confirmed (after 3 months) serum bicarbonate level \< 22 mmol/L (or \< 20 mmol/L if delay of more than 1 hour between sampling and determination)
- 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)
- One of the following diseases during the previous 6 months: myocardial infarction, shock, acute problems of decompensated heart failure or respiratory failure.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT03831464
Start Date
November 5 2019
End Date
December 31 2024
Last Update
December 19 2023
Active Locations (19)
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1
AZ Delta
Roeselare, West-Vlaanderen, Belgium, 8800
2
OLVZ Aalst
Aalst, Belgium
3
Epicura Ath
Ath, Belgium
4
Epicura Baudour
Baudour, Belgium