Metformin as RenoProtector of Progressive Kidney Disease

NCT03831464 | Unknown Phase 3

• 1 other identifier: RenoMet
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 19

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 ) 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).

Conditions

Chronic Kidney Diseases

Keywords

CKD; Metformin; Renoprotector

Outcome Measures

Primary Outcomes (1)

• Reaching a 30% decline of eGFR

  Values of serum creatinine obtained from local determination will be used for the calculation of eGFR.

  Period of 30 months

Secondary Outcomes (11)

• Mortality rate during the investigation period

  Period of 30 months

• Evolution of the renal function

  Period of 30 months

• Percentage of patients developing end-stage renal disease

  Period of 30 months

• Percentage of transplant patients with graft loss

  Period of 30 months

• Evolution of proteinuria

  Difference between baseline and study end

Study Arms (2)

Metformin treatment group

EXPERIMENTAL

Drug: Metformin Hydrochloride

Placebo control group

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

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 .

Metformin treatment group

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.

Placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• University Hospital, Antwerp: collaborator

Study Sites (19)

AZ Delta

Roeselare, West-Vlaanderen, 8800, Belgium

Location

OLVZ Aalst

Aalst, Belgium

Location

Epicura Ath

Ath, Belgium

Location

Epicura Baudour

Baudour, Belgium

Location

Imelda Ziekenhuis Bonheiden

Bonheiden, Belgium

Location

CHU Brugmann

Brussels, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Grand Hôpital de Charleroi

Charleroi, Belgium

Location

Antwerp University Hospital

Edegem, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Jessa Ziekenhuis

Hasselt, Belgium

Location

Centre Hospitalier Régional de la Citadelle

Liège, Belgium

Location

Centre Hospitalier Universitaire Liège (CHU Liège)

Liège, Belgium

Location

Centre Hospitalier Régional de Namur

Namur, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

Centre Hospitalier de Wallonie Picarde

Tournai, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

CHR Verviers

Verviers, Belgium

Location

Related Publications (1)

• El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.

  PMID: 38837240 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Metformin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr.

Model 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),

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 5, 2019
• Study Start: November 5, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

BE (19)