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

This study has been terminated.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00121784
First received: July 15, 2005
Last updated: April 19, 2007
Last verified: April 2007

July 15, 2005
April 19, 2007
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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
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Complete list of historical versions of study NCT00121784 on ClinicalTrials.gov Archive Site
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
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Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients
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

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Transplantation
Drug: mycophenolate mofetil [CellCept]; sirolimus [Rapamune]
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   France,   Germany,   Spain
 
NCT00121784
MT18328
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Hoffmann-La Roche
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Hoffmann-La Roche
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP