EUCTR2012-003987-34-BE
Active, not recruiting
Phase 1
Therapeutic interventions on senescence markers after human kidney transplantation, does metformine meets his expectations?”
Z Leuven0 sites50 target enrollmentJanuary 23, 2013
ConditionsKidney 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: 100000004863MedDRA version: 14.1Level: PTClassification code 10004782Term: Biopsy kidneySystem Organ Class: 10022891 - InvestigationsTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Kidney transplant patients 3 months after TX, witha stable kidney function, no signs of graft failure.No other conditions like heart failure, diabetes, ....
- Sponsor
- Z Leuven
- Enrollment
- 50
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
Exclusion Criteria
- •Exclusion criteria
- •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
Outcomes
Primary Outcomes
Not specified
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