NCT02351427

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

Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

When acute cellular rejection occurred in kidney allograft, investigators administer high dose steroid. However, there is insufficient effect in about 20-30%. Bortezomib acts not only on plasma cells, but also T cells, B cells and dendritic cells. In addition, bortezomib is relatively safe drug compared to thymoglobulin which investigators use in the cases of steroid failure. Therefore, investigators administer bortezomib with steroid in one group, and compared the group with the other group in which conventional steroid treatment is done.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Bortezomib	In one group, investigators administer bortezomib and steroid to manage acute cellular rejection in kidney transplantation, and compare the results with another group in which only steroid was administered.
DRUG	Steroid	Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-01-30
• Last updated: 2015-02-04

Locations

1 site across 1 country: South Korea