Clinical Trials Logo

Clinical Trial Summary

The primary objective is to evaluate the efficacy of desensitization therapy, which includes VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart transplantation.


Clinical Trial Description

Bortezomib works by decreasing plasma cells in the blood. Plasma cells produce antibodies. Plasmapheresis is a procedure that removes antibodies from the blood. Plasma cells and antibodies produced by plasma cells can be involved in organ rejection after transplantation.

This trial will evaluate if decreasing plasma cells and antibodies with bortezomib and plasmapheresis can reduce complications while participants are waiting for their heart transplant. The evaluation of efficacy is defined by a lower complication rate while on the heart transplant waitlist. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01769443
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Terminated
Phase Phase 2
Start date June 2013
Completion date July 2014

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
Terminated NCT00678002 - Quality of Life in Pediatric Transplant Patients
Withdrawn NCT00780377 - Intracoronary Bradykinin Mediated t-PA Release in Heart Transplant Recipients N/A
Withdrawn NCT00780637 - Brachial Artery t-PA Release in Heart Transplant Recipients N/A
Completed NCT01182571 - Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients N/A
Withdrawn NCT00572286 - Non-invasive Evaluation of Heart Transplant Rejection- Pilot Study N/A
Terminated NCT00121784 - Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients Phase 4
Completed NCT00123331 - Rapamycin Use in Calcineurin Inhibitor (CNI)-Free Immunosuppression for Stabilization/Improvement of Renal Function After Heart Transplantation Phase 4