Clinical Trials Logo

Clinical Trial 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).


Clinical Trial 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. Metformin is a well-known and cheap medication used for many years and still used as main treatment of type 2 diabetes. In our study, this 'old' product will be used for a 'new' indication, slowing down the progression of CKD. After randomization in the participating renal care clinic, patients in the intervention group will be treated with metformin at a dose of 1000 mg/day (2x500mg) in the evening during 30 months (Metformin - Glucophage SR (Merck KGaA)). 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 At each visit during the study period, the metformin medication will be hand over to the patient in a HDPE bottle, closed with a MEMS cap (Medication Event Monitoring System). The MEMS a cap that registers the time and date of each opening (presumed intake of the medication in the bottle). Patients blindly randomized to the control group will receive placebo treatment (2 tablets per day) also in a MEMS device and will continue to receive usual care. Control patients will have the same data collection. Follow-up of patients during the entire study period will be the responsibility of the treating nephrologist in the renal care clinic. All patients will have a baseline data collection at study entry (demographics, comorbidities, concomitant medication, clinical parameters, lab results). During the study period of 30 months patients will have follow-up visits at their renal care clinic every four months with collection of follow-up data (concomitant medication, clinical parameters, routine lab results and drug related problems). Extra blood and urine samples will be collected for a centralized second determination of serum creatinine and proteinuria. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03831464
Study type Interventional
Source Universiteit Antwerpen
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 5, 2019
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT06386172 - Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm N/A
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT03434145 - Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases N/A
Recruiting NCT04984226 - Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD Phase 2
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Recruiting NCT05318196 - Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
Terminated NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Not yet recruiting NCT04925661 - HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia Phase 1
Recruiting NCT04961164 - Resistant Starch Prebiotic Effects in Chronic Kidney Disease N/A
Completed NCT05015647 - Low Protein Diet in CKD Patients at Risk of Malnutrition N/A
Completed NCT03426787 - Helping Empower Liver and Kidney Patients N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Completed NCT04363554 - The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease N/A
Recruiting NCT04831021 - Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role? N/A
Terminated NCT04877847 - Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury N/A
Recruiting NCT04422652 - Combination of Novel Therapies for CKD Comorbid Depression Phase 2
Completed NCT05055362 - Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study N/A
Not yet recruiting NCT06330480 - Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease N/A
Recruiting NCT03176862 - Left Ventricular Fibrosis in Chronic Kidney Disease N/A
Terminated NCT02539680 - Intestinal Phosphate Transporter Expression in CKD Patients N/A