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

February 3, 2015 updated by: Su-Kil Park, Asan Medical Center

Bortezomib With Steroid Pulse Therapy for Acute Cellular Rejection in Kidney

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chung Hee Baek, M.D.
  • Phone Number: 82-2-3010-1481
  • Email: bch393@naver.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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.
Other Names:
  • Velcade
Drug: Steroid
Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.
Active Comparator: 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
Drug: Steroid
Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum creatinine
Time Frame: Day 14
Investigators measure patients' serum creatinine at day 14.
Day 14

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Su-Kil Park, M.D., PhD, Division of Nephrology, Department of Internal Medicine, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

January 30, 2015

Study Record Updates

Last Update Posted (Estimate)

February 4, 2015

Last Update Submitted That Met QC Criteria

February 3, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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