NCT01278745

Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation

Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation (CTOT-11)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 362 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function. People who develop antibodies after transplant have a higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the risk of developing CAV. People who develop CAV usually have to receive another transplant.

Detailed description

The purpose of this research study is to see if a study drug called rituximab (Rituxan®) prevents CAV. Rituximab destroys certain types of white blood cells called B cells. B cells are important cells in the immune system that help the body fight infection by producing substances called antibodies. B cells and the antibodies they produce are also involved in some kinds of rejection after organ transplantation. Rituximab decreases the number of B cells in the blood and other tissues. The goal of this study is to determine if decreasing B cells with Rituximab can prevent injury to the transplanted heart.

Conditions

• Cardiac Allograft Vasculopathy
• Heart Transplant Recipients

Interventions

Type	Name	Description
BIOLOGICAL	Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
DRUG	Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper)

Timeline

• Start date: 2011-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2011-01-19
• Last updated: 2020-08-25
• Results posted: 2017-04-11

Locations

24 sites across 1 country: United States