A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
18 Years
N/A
Both
Kidney Transplantation
Trial Information
A Phase II, Open-Label, Concentration-Controlled, Randomized, 6-Month Study of 'Standard Dose' Tacrolimus + Sirolimus + Corticosteroids Compared to 'Reduced Dose' Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
This study evaluated renal graft function based on calculated creatinine clearance at 6
months after transplantation in patients receiving a regimen of 'reduced' or 'standard' dose
tacrolimus plus sirolimus and corticosteroids. Blood serum creatinine, the incidence of
biopsy-confirmed acute graft rejection, and patient and graft survival were also evaluated
at 6 months post transplantation.
Inclusion Criteria
Inclusion criteria
- At least 18 years of age
- End-stage renal disease in patients receiving a primary or secondary renal allograft
from a cadaveric donor
- Patients with secondary kidney transplant must have maintained their primary graft
for at least 6 months
Exclusion criteria
- Planned antibody induction
- Multiple organ transplants
- Patients at high risk of acute rejection
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:
Graft function as measured by calculated creatinine clearance at month 6 post-transplantation.
Principal Investigator
Medical Monitor, MD
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
Germany: Ethics Commission
Study ID:
0468E1-100193
NCT ID:
NCT00518271
Start Date:
April 2000
Completion Date:
June 2002
Related Keywords:
- Kidney Transplantation
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