Glucophage trial

Phase 1

• Conditions: Kidney transplant patients 3 months after TX, witha stable kidney function, no signs of graft failure.No other conditions like heart failure, diabetes, ....; MedDRA version: 14.1Level: LLTClassification code 10069030Term: Graft failureSystem Organ Class: 100000004863; MedDRA version: 14.1Level: PTClassification code 10004782Term: Biopsy kidneySystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-003987-34-BE
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-23
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion criteria
•Renal transplant patients
•Baseline biopsy on day of transplantation
•Inclusion on day of first protocol biopsy (month 3) in case of stable renal function
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Exclusion criteria
•Age > 75
•Unstable or acute congestive heart failure (Ejection fraction < 45%)
•Lung disease
•Liver disease
•GFR < 30 ml/min
•Diabetes Mellitus
•Past history of lactic acidosis
•Alcohol abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1.Long-term histology (fibrosis, atrophy, glomerulosclerosis and arterial hyalinosis)<br>2.Expression of senescence markers in the kidney transplant<br>3.Graft function and graft survival <br>;Secondary Objective: 1.Long-term histology (fibrosis, atrophy, glomerulosclerosis and arterial hyalinosis)<br>2.Expression of senescence markers in the kidney transplant<br>3.Graft function and graft survival <br>;Primary end point(s): 1.Long-term histology (fibrosis, atrophy, glomerulosclerosis and arterial hyalinosis)<br>2.Expression of senescence markers in the kidney transplant<br>3.Graft function and graft survival <br>;Timepoint(s) of evaluation of this end point: 1.Long-term histology (fibrosis, atrophy, glomerulosclerosis and arterial hyalinosis) 1 year<br>2.Expression of senescence markers in the kidney transplant<br>2 years<br>3.Graft function and graft survival <br>5 years<br>

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1.Long-term histology (fibrosis, atrophy, glomerulosclerosis and arterial hyalinosis) 1 year<br>2.Expression of senescence markers in the kidney transplant<br>2 years<br>3.Graft function and graft survival <br>5 years;Secondary end point(s): 1.Long-term histology (fibrosis, atrophy, glomerulosclerosis and arterial hyalinosis) 1 year<br>2.Expression of senescence markers in the kidney transplant<br>2 years<br>3.Graft function and graft survival <br>5 years