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

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High dose IVIG and B cell depleting agents
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Waiting list, Deceased donor kidney transplantation, Desensitization, anti HLA antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group 1

Group 2

Arm Description

This group will not receive IVIG and B cell depleting agents

This group will receive IVIG and B cell depleting agents

Outcomes

Primary Outcome Measures

The rates of kidney transplantation

Secondary Outcome Measures

Reduction in anti-HLA alloantibodies
Renal allograft survival
graft and patient survival
The number of serious complication

Full Information

First Posted
December 24, 2011
Last Updated
January 5, 2012
Sponsor
Seoul National University Hospital
Collaborators
Roche Pharma AG
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1. Study Identification

Unique Protocol Identification Number
NCT01502267
Brief Title
Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant
Official Title
Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
Roche Pharma AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Waiting list, Deceased donor kidney transplantation, Desensitization, anti HLA antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
This group will not receive IVIG and B cell depleting agents
Arm Title
Group 2
Arm Type
Experimental
Arm Description
This group will receive IVIG and B cell depleting agents
Intervention Type
Drug
Intervention Name(s)
High dose IVIG and B cell depleting agents
Other Intervention Name(s)
IVIG, Mabthera, Velcade
Intervention Description
IVIG(2g/kg two times on day 1, 30) Rituximab(375mg/m2 on day 3) Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)
Primary Outcome Measure Information:
Title
The rates of kidney transplantation
Time Frame
from one to five years
Secondary Outcome Measure Information:
Title
Reduction in anti-HLA alloantibodies
Time Frame
1year
Title
Renal allograft survival
Description
graft and patient survival
Time Frame
from one to five year
Title
The number of serious complication
Time Frame
from one to five year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curie Ahn, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26844479
Citation
Jeong JC, Jambaldorj E, Kwon HY, Kim MG, Im HJ, Jeon HJ, In JW, Han M, Koo TY, Chung J, Song EY, Ahn C, Yang J. Desensitization Using Bortezomib and High-dose Immunoglobulin Increases Rate of Deceased Donor Kidney Transplantation. Medicine (Baltimore). 2016 Feb;95(5):e2635. doi: 10.1097/MD.0000000000002635.
Results Reference
derived

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

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