Status:
COMPLETED
Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Renal Allograft Recipients
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American des...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor.
- Age \>= 13 years, weight \>= 40 kg
- Women must have a negative pregnancy test at study entry
- Exclusion criteria
- Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult)
- Active systemic infection, or localized major infection or known HIV
- Patients with residual kidney function \>20 mL/min
Exclusion
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2004
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00470665
Start Date
August 1 2002
End Date
July 1 2004
Last Update
May 8 2007
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