Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization

Phase 2 Terminated 102 enrolled Alexion Pharmaceuticals, Inc.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization therapy.

Timeline

Start: 2011-11-02
Primary completion: 2014-05-13
Completion: 2015-11-13

Outcome

Missed primary endpoint

Stopped: “Did not achieve statistical significance for primary endpoint”

registry analysis (superiority test); Eculizumab vs Standard of Care; p = 0.76; Proportion difference -3.9 (95% CI -23.9 to 16.3); Fisher Exact NCT01399593 ↗

Publications

Marks WH, Mamode N, Montgomery RA, Stegall MD, Ratner LE, Cornell LD, Rowshani AT, Colvin RB, Dain B, Boice JA, Glotz D; C10-001 Study Group. Safety and efficacy of eculizumab in the prevention of antibody-mediated rejection in living-donor kidney transplant recipients requiring desensitization therapy: A randomized trial. Am J Transplant. 2019 Oct;19(10):2876-2888. doi: 10.1111/ajt.15364. Epub 2019 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eculizumab	Monoclonal antibody	1200 mg	Intravenous