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

Phase 2

• Conditions: End Stage Renal Disease
• Interventions: Drug: High dose IVIG and B cell depleting agents

• Registration Number: NCT01502267
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-12-24
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-05
• Last Update Posted: 2012-01-06
• Primary Completion: 2014-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 2	High dose IVIG and B cell depleting agents	This group will receive IVIG and B cell depleting agents

Primary Outcome Measures

Name	Time	Method
The rates of kidney transplantation	from one to five years

Secondary Outcome Measures

Name	Time	Method
Reduction in anti-HLA alloantibodies	1year
Renal allograft survival	from one to five year	graft and patient survival
The number of serious complication	from one to five year

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of