Glucophage trial

“Therapeutic interventions on senescence markers after human kidney transplantation, does metformine meets his expectations?”

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003987-34-BE

Enrollment

Registered

2013-01-23

Start date

2013-03-19

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney transplant patients 3 months after TX, with a stable kidney function, no signs of graft failure. No other conditions like heart failure, diabetes, .... MedDRA version: 14.1 Level: LLT Classification code 10069030 Term: Graft failure System Organ Class: 100000004863 MedDRA version: 14.1 Level: PT Classification code 10004782 Term: Biopsy kidney System Organ Class: 10022891 - Investigations

Interventions

Trade Name: glucophage 500 mg (metformax) Product Name: Glucophage 500 mg PL Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

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

Measure

Time frame

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

—

Countries

Belgium

Contacts

Public ContactKatrien De Vusser

UZ Leuven

katrien.devusser@uzleuven.be0032479890680

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026