Metformin Use in Chronic Kidney Disease: The CKD-Met Study

Type 2 Diabetes Clinical Trial

— CKD-Met  

Official title:

Metformin Use in Chronic Kidney Disease: The CKD-Met Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844153
• Other study ID #: 69HCL16_0408
• Status: Recruiting
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 25, 2016
• Start date: March 2014
• Est. completion date: March 2020

Study information

• Verified date: July 2016
• Source: Hospices Civils de Lyon
• Contact: Denis FOUQUE, MD PhD
• Phone: (0)4 7267 8704
• Email: denis.fouque[@]univ-lyon1.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial Summary

Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit.

Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients.

The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or more

• Type 2 diabetes

• Seen by a nephrologist (consultation or hospitalization) between March 2014 and March 2020 in the Department of Nephrology, Lyon Sud university hospital, France

Exclusion Criteria:

• On-going treatment by dialysis

• Kidney transplantation

• Type 1 diabetes

• Missing data (metformin treatment)

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes

Intervention

Other:
• modalities of metformin prescription
Metformin prescription or not, in each CKD stage

Locations

Country	Name	City	State
France	Claude Bernard University, Lyon, France, Lyon Sud university hospital	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients receiving metformin	metformin use during chronic kidney disease. Percentage of patients receiving metformin will be recorded.	every January 1st up to 2020	No
Secondary	Dose of metformin	metformin use during chronic kidney disease. Dose of metformin will be recorded.	every January 1st up to 2020	No
Secondary	Occurence of reasons for non-prescription of metformin	metformin use during chronic kidney disease. Occurence of reasons for non-prescription of metformin will be recorded.	every January 1st up to 2020	No
Secondary	CKD stages	CKD stages will be recorded.	every January 1st up to 2020	No
Secondary	Doses of oral antidiabetes medications	Oral antidiabetic medications use during chronic kidney disease. Doses of oral antidiabetes medications (sulfonylureas, alpha-glucosidase inhibitors, Dipeptidyl peptidase-4 (DPP4) inhibitors, incretin mimetics, SGLT2 inhibitors) will be recorded.	every January 1st up to 2020	No
Secondary	starting time of insulin	need for insulin	every January 1st up to 2020	No
Secondary	occurrence of lactic acidosis	data file analysis and record of lactic acidosis episodes	every January 1st up to 2020	No