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

Seoul National University Hospital2 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

High dose IVIG and B cell depleting agentsDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

The rates of kidney transplantation

Time frame: from one to five years

Secondary Outcomes

Reduction in anti-HLA alloantibodies

Time frame: 1year

Renal allograft survival

graft and patient survival

Time frame: from one to five year

The number of serious complication

Time frame: from one to five year

Data from ClinicalTrials.gov

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