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

Stopped early · Phase 4

Conditions studied: Heart Transplantation

In brief

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.

Key facts

Study ID

NCT00121784

Run by

Hoffmann-La Roche

People needed

12

Starts

2005-10-01

Expected to finish

2006-08-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Chicago, Illinois, United States
• Study site — Maywood, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Darlinghurst, Australia
• Study site — Perth, Australia
• Study site — Prahran, Australia
• Study site — Innsbruck, Austria
• Study site — Marseille, France
• Study site — Nantes, France
• Study site — Paris, France
• Study site — Paris, France
• Study site — Rennes, France
• Study site — Rouen, France
• Study site — Tours, France
• Study site — Vandœuvre-lès-Nancy, France
• Study site — Berlin, Germany
• Study site — Hanover, Germany

Full record on ClinicalTrials.gov

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