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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00121784
Recruitment Status : Terminated (Poor recruitment)
First Posted : July 21, 2005
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Heart Transplantation Drug: mycophenolate mofetil [CellCept] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2005
Primary Completion Date : August 2006
Study Completion Date : August 2006

Arm Intervention/treatment
Experimental: 1
Drug: mycophenolate mofetil [CellCept]

Primary Outcome Measures :
  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\n

Secondary Outcome Measures :
  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\n

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00121784

  Hide Study Locations
United States, Illinois
Chicago, Illinois, United States, 60637
Maywood, Illinois, United States, 60153
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19102
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Memphis, Tennessee, United States, 38120
United States, Texas
Dallas, Texas, United States, 75230
United States, Utah
Salt Lake City, Utah, United States, 84148
Darlinghurst, Australia, 2010
Perth, Australia, 6847
Prahran, Australia, 3181
Innsbruck, Austria, 6020
Marseille, France, 13385
Nantes, France, 44093
Paris, France, 75651
Paris, France, 75908
Rennes, France, 35033
Rouen, France, 76031
Tours, France, 37044
Vandoeuvre-les-nancy, France, 54511
Berlin, Germany, 13353
Hannover, Germany, 30625
Heidelberg, Germany, 69120
Jena, Germany, 07740
Madrid, Spain, 28007
Pamplona, Spain, 31008
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00121784     History of Changes
Other Study ID Numbers: MT18328
First Posted: July 21, 2005    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Mycophenolic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action