Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant

January 5, 2012 updated by: Seoul National University Hospital

Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients

The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-799
        • Seoul National University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18
  • patients who are on the waiting list more than 4 years
  • PRA I or II > 50%

Exclusion Criteria:

  • Recent recipients of any live attenuated vaccine(s) within 4 weeks
  • Subjects who have received IVIG or B cell depleting agents previously
  • Subjects with positive result for viral hepatitis(B,C) or HIV infection
  • Subjects with active infection
  • Lactating or pregnant females
  • Subjects who have history of malignancy in recent 5years
  • Subjects who have experience of treatment for the psychiatric problem in recent 6months
  • Subjects who have hematologic abnormality (Hb < 7g/dL, Platelet < 100,000/mm3, AST/ALT > 80IU)

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1
This group will not receive IVIG and B cell depleting agents
Experimental: Group 2
This group will receive IVIG and B cell depleting agents
Drug: High dose IVIG and B cell depleting agents
  1. IVIG(2g/kg two times on day 1, 30)
  2. Rituximab(375mg/m2 on day 3)
  3. Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)
Other Names:
  • Velcade
  • Mabthera
  • IVIG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rates of kidney transplantation
Time Frame: from one to five years
from one to five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in anti-HLA alloantibodies
Time Frame: 1year
1year
Renal allograft survival
Time Frame: from one to five year
graft and patient survival
from one to five year
The number of serious complication
Time Frame: from one to five year
from one to five year

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Curie Ahn, MD, Seoul National University Hospital

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

January 1, 2010

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

December 24, 2011

First Submitted That Met QC Criteria

December 29, 2011

First Posted (Estimate)

December 30, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2012

Last Update Submitted That Met QC Criteria

January 5, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11374

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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