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drugset / Trial / NCT00121810

Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

NCT00121810 ↗

Phase 4 Completed 305 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2003-08
Primary completion
2009-11
Completion
2009-11

Outcome

Met primary endpoint

registry Mycophenolate Mofetil + Sirolimus vs Mycophenolate Mofetil + Cyclosporine or Tacrolimus; p = 0.012; Median Difference (Net) 18.7 (95% CI 4.2 to 33.2) NCT00121810 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule — —
Background Mycophenolate Mofetil Small molecule 1 g Oral
Background Mycophenolate Mofetil Small molecule 1.5 g Oral

Indications

No indication recorded.