Phase 3
N=79
Study Evaluating Rapamune® Maintenance Regimen
Renal Transplant
Bottom Line
View on ClinicalTrials.gov: NCT00478608 ↗Enrolled (actual)
79
Serious AEs
49.4%
Results posted
Jan 2010
Primary outcome: Primary: Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. — 12 patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sirolimus (Rapamune®) (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation. |
12 | — |
| SECONDARY Glomerular Filtration Rate (GFR) (Nankivell Method) |
67.36; 71.92 | — |
| SECONDARY Serum Creatinine |
9.42; 1.30; 1.25 | — |
| SECONDARY Patient and Graft Survival |
77; 76; 77; 76 | — |
| SECONDARY Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation |
15 | — |
Summary
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.
Secondary :
1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 13 years of age.
- End-stage renal disease in patients scheduled to receive a primary renal allograft from a cadaveric donor, a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor. A mismatch donor is defined as a donor human leukocyte antigen (HLA) antigen not shared by the patient.
- Patients with a panel of reactive antibody (%PRA) less than or equal to 50%
Exclusion Criteria
- 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.
- Chronic anti-arrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery.
- History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin).
- Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists.
Data sourced from ClinicalTrials.gov (NCT00478608). 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.