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

Phase 3

• Conditions: Kidney Transplantation
• Interventions: Drug: Steroid; Drug: Bortezomib

• Registration Number: NCT02351427
• Lead Sponsor: Asan Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Status Verified: 2015-02
• Study Start: 2015-02
• Last Update Submitted: 2015-02-03
• Last Update Posted: 2015-02-04
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Steroid	Steroid	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
Bortezomib	Steroid	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
Bortezomib	Bortezomib	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

Primary Outcome Measures

Name	Time	Method
Serum creatinine	Day 14	Investigators measure patients' serum creatinine at day 14.

Secondary Outcome Measures

Name	Time	Method
Incidence of steroid failure	Day 7	Steroid failure is defined as serum creatinine at day 8 ≥ serum creatinine at day 0.
Serum creatinine	Month 1	Investigators measure patients' serum creatinine at month 1.
Infection	Until 1 year after intervention	Infection as measured by clinical, laboratory and microbiological data
Recurrence of Rejection	Until 1 year after intervention	Recurrence of rejection as measured by clinical and laboratory data with graft biopsy.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of