Status:
TERMINATED
Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Heart Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 eithe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00121784
Start Date
October 1 2005
End Date
August 1 2006
Last Update
November 2 2016
Active Locations (29)
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1
Chicago, Illinois, United States, 60637
2
Maywood, Illinois, United States, 60153
3
Boston, Massachusetts, United States, 02115
4
Detroit, Michigan, United States, 48202-2689