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

Phase 2 Terminated 362 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trials in Organ Transplantation · collab Genentech, Inc. · collab National Heart, Lung, and Blood Institute (NHLBI) · collab Rho Federal Systems Division, Inc. · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2011-09
Primary completion: 2015-10
Completion: 2015-10

Outcome

Missed primary endpoint

Stopped (Enrollment): “Due to inability to meet accrual goals within the funding period”

paper The mean ± SD change in PAV at 12 months was +6.8 ± 8.2% rituximab versus +1.9 ± 4.4% placebo (p = 0.0019). PMID 31272550 ↗

paper A marked, unexpected increase in coronary artery PAV with rituximab was observed during the first year in HTX recipients. PMID 31272550 ↗

Publications

Results Starling RC, Armstrong B, Bridges ND, Eisen H, Givertz MM, Kfoury AG, Kobashigawa J, Ikle D, Morrison Y, Pinney S, Stehlik J, Tripathi S, Sayegh MH, Chandraker A; CTOT-11 Study Investigators. Accelerated Allograft Vasculopathy With Rituximab After Cardiac Transplantation. J Am Coll Cardiol. 2019 Jul 9;74(1):36-51. doi: 10.1016/j.jacc.2019.04.056.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rituximab	Monoclonal antibody	1000 mg	Intravenous
Background	MMF	Unknown	—	—
Comparator	MMF	Unknown	—	—
Comparator	Tacrolimus	Small molecule	—	—

Indications

No indication recorded.