Clinical Trials Logo
  1. Home
  2. Heart Transplantation
  3. NCT00121784

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

Heart Transplantation Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00121784
Study type Interventional
Source Hoffmann-La Roche
Contact
Status Terminated
Phase Phase 4
Start date October 2005
Completion date August 2006
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06035991 - First Clinical Evaluation of Heart Transplantation With Grafts Preserved Using an Ex-vivo Extended Perfusion System N/A
Recruiting NCT01927614 - Advanced Cardiac Imaging in Cardiac Allograft Vasculopathy N/A
Recruiting NCT01705015 - Organ Transplantation Rehabilitation: Effect of Bedside Exercise Device and Activity Reinforcement N/A
Completed NCT01655563 - Pharmacogenetic Trial of Tacrolimus After Pediatric Transplantation Phase 2
Completed NCT01028599 - Effect of Physical Training on Oxygen Uptake and Endothelial Function in Heart Transplant Recipients N/A
Completed NCT00531921 - Effects of Donor and Recipient Genetic Expression on Heart, Lung, Liver, or Kidney Transplant Survival N/A
Terminated NCT00420537 - Shift to Everolimus (RAD) Kidney Sparing Study Phase 4
Enrolling by invitation NCT03292861 - The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients Phase 2
Recruiting NCT04924491 - Cell Therapy With Treg Cells Obtained From Thymic Tissue (thyTreg) to Prevent Rejection in Heart Transplant Children Phase 1/Phase 2
Recruiting NCT05270902 - Haemoadsorption During Heart Transplantation N/A
Completed NCT05289180 - Brachial Right Ventricle - Endomyocardial Biopsy
Recruiting NCT03687723 - Observational Study of the Clinical Use of the OCS™ Heart
Completed NCT01091194 - Effect of Exercise After Heart Transplantation Phase 2
Completed NCT01182571 - Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients N/A
Withdrawn NCT00780637 - Brachial Artery t-PA Release in Heart Transplant Recipients N/A
Terminated NCT00678002 - Quality of Life in Pediatric Transplant Patients
Withdrawn NCT00780377 - Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients N/A
Withdrawn NCT00572286 - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study N/A
Completed NCT00123331 - Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation Phase 4
Completed NCT00690157 - Registry of Patients Referred for Heart Transplantation N/A