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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01502267

Enrollment

Registered

2011-12-30

Start date

2010-01-31

Completion date

2016-01-31

Last updated

2012-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Waiting list, Deceased donor kidney transplantation, Desensitization, anti HLA antibody

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.

Interventions

DRUGHigh 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)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
The rates of kidney transplantation	from one to five years

Secondary

Measure	Time frame	Description
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	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026