NCT00782821

Randomized Trial of Induction Therapies in High Immunological Risk Kidney Transplant Recipients

Targeted Therapy for High Immunologic Risk Renal Transplant Recipients: A Prospective, Randomized, Open-Label Pilot Study of B-Cell Depleting Therapy in Combination With Anti-Thymocyte Globulin [Rabbit] (Thymoglobulin®, Genzyme), Tacrolimus (Prograf®, Astellas), Mycophenolate Mofetil (CellCept®, Roche) and Corticosteroid Minimization

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out the effects of adding B lymphocyte modulating agents in patients at risk for rejection receiving an anti-rejection (immunosuppressive) regimen of Thymoglobulin® induction with Prograf®, Cellcept® and corticosteroid therapy.

Detailed description

Optimal induction regimens for patients at high risk for antibody and/or cell-mediated rejection have not been established. This pilot, prospective, randomized study evaluated addition of B cell/plasma cell-targeting agents to T cell-based induction with rabbit antithymocyte globulin (rATG) in high immunologic risk renal transplant recipients. Patients were randomized to induction with rATG, rATGþrituximab, rATGþbortezomib or rATGþrituximabþbortezomib.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Rabbit Antithymocyte Globulin	rATG will be given 1.5mg/kg intravenous (IV) per dose.
DRUG	Velcade	Velcade will be given 1.3mg/m2 via intravenous push (IVP) per dose.
DRUG	Rituxan	Given via IV per group assignment.

Timeline

• Start date: 2008-09-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2008-10-31
• Last updated: 2016-01-20
• Results posted: 2016-01-20

Locations

2 sites across 1 country: United States