Trial information
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
Status: Terminated
Protocol number: MT18328
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of replacing CNI with sirolimus in a standard care regimen of CNI, CellCept, and steroids on renal function in heart transplant patients
Brief 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.
Target sample size is 580.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Heart Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil [CellCept]
Primary outcome: 1. Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up
Key secondary outcomes: 1. Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC
Inclusion criteria:
- adult (>=18 years of age) heart transplant patients (4-6 weeks post-transplant);
- receipt of first heart (single-organ) transplant;
- standard care regimen of CNI, MMF, and corticosteroids since transplantation.
Exclusion criteria:
- positive donor-specific cross-match at time of transplantation;
- history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years;
- patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/22/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Germany
