| Trial ID: | L0049 |
| Source ID: | NCT03831464
|
| Associated Drug: |
Metformin Hydrochloride
|
| Title: |
Metformin as RenoProtector of Progressive Kidney Disease
|
| Acronym: |
RenoMet
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases
|
| Interventions: |
DRUG: Metformin Hydrochloride|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: 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: Mortality rate during the investigation period, The time to the event of all-cause mortality will be compared between Metformin and placebo., Period of 30 months|Evolution of the renal function, Expressed as the slopes of the 8 eGFR determinations during the study period, Period of 30 months|Percentage of patients developing end-stage renal disease, The time to development a doubling of serum creatinine or end-stage renal failure will be compared between Metformin and placebo., Period of 30 months|Percentage of transplant patients with graft loss, The time to the event of graft loss will be compared in the Transplant group between Metformin and placebo using a log-rank test. Kaplan Meier curves will be used to describe the data graphically., Period of 30 months|Evolution of proteinuria, This will be examined by a generalized linear mixed models using baseline measurement and study end measurement., Difference between baseline and study end|Evolution of hypertension, This will be examined by a generalized linear mixed models using baseline measurement and study end measurement., Difference between baseline and study end|Frequency of Major Adverse Cardiovascular Events, This will be examined by a generalized linear mixed models using baseline measurement and study end measurement. This model will allow inclusion of correcting variables., Period of 30 months|Hospitalization during the investigation period, Hospitalization during the investigation period will be studied using a Cox regression with multiple events., Period of 30 months|Hospitalization during the investigation period, Total number of hospitalization days will be analyzed using a multiple regression model., Period of 30 months|(Serious) Adverse drug events, Number of lactic acidosis events, number of deaths related to lactic acidosis, other adverse events. Reported selected AEs and all SAEs will be summarized using descriptive statistics and a comparison between Metformin and placebo group will be performed., Period of 30 months|Evolution of Quality of life, During the study period (area under the curve as well as difference between baseline and study end) of the utility Qol score of the EQ-5D-5L questionnaire. Quality of life as measured during the follow-up visits as well as the evolution of Qol during the trial will be compared between Metformin and placebo group., Period of 30 months
|
| Sponsor/Collaborators: |
Sponsor: Universiteit Antwerpen | Collaborators: University Hospital, Antwerp
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
290
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2019-11-05
|
| Completion Date: |
2024-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2023-12-19
|
| Locations: |
AZ Delta, Roeselare, West-Vlaanderen, 8800, Belgium|OLVZ Aalst, Aalst, Belgium|Epicura Ath, Ath, Belgium|Epicura Baudour, Baudour, Belgium|Imelda Ziekenhuis Bonheiden, Bonheiden, Belgium|Hôpital Erasme, Brussels, Belgium|CHU Brugmann, Brussel, Belgium|UZ Brussel, Brussel, Belgium|Grand Hôpital de Charleroi, Charleroi, Belgium|Antwerp University Hospital, Edegem, Belgium|Ghent University Hospital, Ghent, Belgium|Jessa Ziekenhuis, Hasselt, Belgium|Centre Hospitalier Régional de la Citadelle, Liège, Belgium|Centre Hospitalier Universitaire Liège (CHU Liège), Liège, Belgium|Centre Hospitalier Régional de Namur, Namur, Belgium|AZ Nikolaas, Sint-Niklaas, Belgium|Centre Hospitalier de Wallonie Picarde, Tournai, Belgium|AZ Turnhout, Turnhout, Belgium|CHR Verviers, Verviers, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT03831464
|
