Clinical trial NCT00121784: Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
Official 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Heart Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-07-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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\n
Secondary outcomes:
measure: 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\n
Other outcomes:
Locations:
city: Chicago
country: United States
state: Illinois
city: Maywood
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Darlinghurst
country: Australia
city: Perth
country: Australia
city: Prahran
country: Australia
city: Innsbruck
country: Austria
city: Marseille
country: France
city: Nantes
country: France
city: Paris
country: France
city: Paris
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Tours
country: France
city: Vandoeuvre-les-nancy
country: France
city: Berlin
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Madrid
country: Spain
city: Pamplona
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: