At a glance
ClinicalIndex Comparison Record- ✓Adult age 18-75 years
- ✓Kidney transplant 30-180 days post-transplantation
- ✓Currently on cyclosporine or tacrolimus, mycophenolate mofetil, and corticosteroids for >14 days prior to entry
- ✓No known contraindications to sirolimus
- ✕Multiple organ transplant or secondary kidney transplant recipients
- ✕Corticosteroid-resistant rejection within 90 days prior to study entry or corticosteroid-sensitive rejection within 30 days prior to study entry
- ✕More than 1 biopsy-proven acute rejection episode prior to study entry
- ✕Prior treatment with sirolimus
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Early Calcineurin Inhibitor Withdrawal in Recipients of Primary Renal Allografts Maintained Long-term on Mycophenolate Mofetil (MMF) (CellCept®) and Sirolimus (Rapamune®)
In Brief
A Phase 4 clinical trial evaluating mycophenolate mofetil [CellCept], Corticosteroids, and 2 other interventions for Kidney Transplantation. Completed, enrolled 305 participants across 36 sites.
Detailed Summary
This 2-arm study recruited kidney transplant patients who were receiving standard care of calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily) and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was discontinued and replaced by sirolimus therapy (in combination with CellCept and corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.
Study Details
Timeline
Interventions
1.0-1.5 g oral dose twice daily
As prescribed
As prescribed
As prescribed