Status:
COMPLETED
Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Graft Rejection
Kidney Failure
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Evaluate renal graft function (based on the calculated Glomerular Filtration Rate) at 12 months after transplantation in patients receiving either a regimen of sirolimus plus mycophenolate mofetil fol...
Eligibility Criteria
Inclusion
- Age: 18 and \< 65 years
- End-stage renal disease, with patients scheduled to receive a primary renal allograft from a cadaveric donor
- Patients receiving a second transplant without an immunological loss of their first graft in the first six months of transplant
Exclusion
- Evidence of active systemic or localized major infection at the time of initial sirolimus administration
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening
- Use of any investigational drug or treatment up to 4 weeks prior to enrollment to the study and during the 12-month treatment phase
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
January 1 2005
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00261820
End Date
January 1 2005
Last Update
May 19 2006
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