NCT00771875

Randomized Trial for Mixed Acute Rejection

B-Cell Targeted Therapy for Acute Renal Allograft Rejection With an Antibody Mediated Component: A Prospective, Randomized, Open-Label Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.

Detailed description

The purpose of the study is to determine safety and efficacy of treatment if mixed (cellular and antibody) mediated acute rejection with addition of B-cell depleting therapy to Thymoglobulin in kidney and simultaneous kidney pancreas allograft recipients.

Conditions

• Graft Rejection

Interventions

Type	Name	Description
DRUG	Rabbit Antithymocyte Globulin (RATG)	All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
DRUG	Rituximab	Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
DRUG	Bortezomib	Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
DRUG	Acetaminophen	Patients will be premedicated with acetaminophen prior to dosing per institution standard of care.
DRUG	Antihistamine	Patients will be premedicated with an antihistamine prior to dosing per institution standard of care.
DRUG	Methylprednisolone	Methylprednisolone 250 mg with 1st dose of Thymoglobulin. Methylprednisolone 125 mg on treatment day 2 subsequent corticosteroids per institution standard of care; following treatment, corticosteroid therapy will resume at the pre-rejection dose.

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2008-10-15
• Last updated: 2016-01-27
• Results posted: 2016-01-27

Locations

2 sites across 1 country: United States