Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols

Phase 4 Completed 200 enrolled University of Miami

RandomizedParallel-groupOpen-labelPrevention

Summary

The purpose of the present study is to determine which antibody induction regimen will result in a safer and more effective method to use with steroid avoidance in renal transplant recipients. Patients receiving either first cadaveric or non-HLA identical living donor kidney transplants will be preoperatively randomized into 2 groups.

Timeline

Start: 2006-02
Primary completion: 2010-05
Completion: 2010-05

Outcome

Missed primary endpoint

paper there were no differences in BPAR rates PMID 22027927 ↗

Publications

Results Ciancio G, Gaynor JJ, Sageshima J, Guerra G, Zarak A, Roth D, Brown R, Kupin W, Chen L, Hanson L, Tueros L, Ruiz P, Livingstone AS, Burke GW 3rd. Randomized trial of dual antibody induction therapy with steroid avoidance in renal transplantation. Transplantation. 2011 Dec 27;92(12):1348-57. doi: 10.1097/TP.0b013e3182384b21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alemtuzumab	Monoclonal antibody	0.3 mg/kg	—
Comparator	Daclizumab	Monoclonal antibody	—	—
Subject	Thymoglobulin	Protein / enzyme biologic	1 mg/kg	—

Indications

No indication recorded.