Expired Study
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Charleston, South Carolina 29425


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

MT18328


NCT ID:

NCT00121784


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Poor recruitment


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Trials
Study Chair
Hoffmann-La Roche

Study Dates

Start Date:October 2005
Completion Date:August 2006
Completion Type:Actual
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:November 2016
Last Changed Date:November 1, 2016
First Received Date:July 15, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:mycophenolate mofetil [CellCept]
Description:1
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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