Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney Transplantation

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Bortezomib; Methylprednisolone

Criteria

Inclusion Criteria:

• living donor kidney transplantation recipients

• patients who were performed kidney biopsies because of laboratory and clinically suspected rejection

• Biopsy proven acute cellular rejection (Banff I - IIA) with C4d negative

• Single luminex panel reactive antibody (PRA) I & II mean fluorescent intensity (MFI) < 3000

Exclusion Criteria:

• patients who received other major organ transplantation

• combined with urinary tract infection or obstruction

• combined with acute antibody mediated rejection

• poor compliance