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

November 1, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: mycophenolate mofetil [CellCept]
1

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

July 15, 2005

First Submitted That Met QC Criteria

July 15, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT18328

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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