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

Roche

Status and phase

Terminated

Phase 4

Conditions

Heart Transplantation

Treatments

Drug: mycophenolate mofetil [CellCept]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00121784

MT18328

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.