A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Kidney Transplantation
Both
Kidney Transplantation
Trial Information
A Randomised, Multicenter, Open-label Study Evaluating the Impact on the Fibrosis at Week 52 of an Early Biopsy at (D10) Versus Standard Management in Patients Who Have Undergone de Novo Renal Transplantation and Received a Marginal Organ Transplant
Inclusion Criteria:
- adult patients, >=18 years of age;
- in receipt of an initial cadaveric kidney transplant;
- in receipt of graft with biopsy;
- in receipt of a 'marginal' kidney transplant.
Exclusion Criteria:
- in receipt of a second kidney transplant;
- in receipt of a multi-organ transplant or a double kidney transplant;
- malignant tumor, or a history of cancer in past 5 years, other than successfully
treated basal cell or spinocellular cancer or cancer in situ of cervix;
- replicating hepatitis B and/or C, or HIV positive serology.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Proportion of patients with >=25% increase in fibrosis score
Outcome Time Frame:
Day 0 to Week 52
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France:AFSSAPS
Study ID:
ML21655
NCT ID:
NCT00817687
Start Date:
January 2009
Completion Date:
January 2012
Related Keywords:
- Kidney Transplantation
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