Phase 3
N=61
Study Evaluating Sirolimus in Kidney Transplant Recipients
Graft vs Host Disease · Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00195273 ↗Enrolled (actual)
61
Serious AEs
—
Results posted
Sep 2009
Primary outcome: Primary: Mean Creatinine Clearance Rate — 56.800; 53.449 ml/min — p=0.6081
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- sirolimus (Drug); cyclosporine (Drug); mycophenolate mofetil (Drug); corticosteroids (Drug); daclizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Creatinine Clearance Rate |
56.800; 53.449 | 0.6081 |
| SECONDARY Number of Patients With Acute Rejection |
3; 9; 5; 10 | — |
| SECONDARY Patient and Graft Survival |
31; 29; 0; 3 | — |
| SECONDARY Mean Creatinine Clearance Rate - 3 Months |
55.200; 51.878 | 0.4662 |
Summary
The purpose of this study is to compare the kidney function in patients who have received a transplanted kidney and were treated with the combination of sirolimus, daclizumab, mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine, mycophenolate and corticosteroids.
Eligibility Criteria
Inclusion Criteria
- Kidney transplantation
- Donor must be at least 60 years old.
Exclusion Criteria
- Current systemic infection
- Unstable angina or treatment for serious arrhythmia.
- Cancer within the previous 5 years.
Data sourced from ClinicalTrials.gov (NCT00195273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.