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

Asan Medical Center

Status and phase: Unknown; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: Steroid; Drug: Bortezomib

Study type: Interventional

Funder types: Other

Identifiers

NCT02351427

2014-1223

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Bortezomib

Active Comparator group

Description:

Bortezomib (subcutaneous) 1.3mg/m2 on day 1, 4 and 7 with Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage

Treatment:

Drug: Bortezomib

Drug: Steroid

Steroid

Active Comparator group

Description:

Steroid - Methylprednisolone (intravenous) Day 1 - 7: 500 mg/500 mg/500 mg/250 mg/250 mg/125 mg/125 mg After day 7: prednisolone (oral) 30 - 60 mg, then taper the dosage

Treatment:

Drug: Steroid