Phase 3
Completed N=830
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
Renal Transplantation
Source: ClinicalTrials.gov NCT00038948 ↗
Enrolled (actual)
830
Serious AEs
15.3%
Results posted
May 2010
Primary outcomePrimary: Nankivell Glomerular Filtration Rate (GFR) — 24.56; 27.24; 59.04; 57.73 mL/min — p=0.575
Summary
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nankivell Glomerular Filtration Rate (GFR) |
24.56; 27.24; 59.04; 57.73 | 0.575 |
| SECONDARY First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. |
4; 0; 8; 3; 7; 3 | 0.135 |
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 13 years.
- Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
- Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization
Exclusion Criteria
- Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
- Patients in whom kidney-pancreas or other multiple organ transplants have been performed
Data sourced from ClinicalTrials.gov (NCT00038948). 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. Informational only — not medical advice.