Overview

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

Status:
Terminated

Trial end date:
2006-08-01

Target enrollment:

Participant gender:

Summary

Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Phase:

Phase 4

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Mycophenolate mofetil
Mycophenolic Acid
Sirolimus