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

NCT ID: NCT01502267

Last Updated: 2012-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

This group will not receive IVIG and B cell depleting agents

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group 2

This group will receive IVIG and B cell depleting agents

Group Type: EXPERIMENTAL

High dose IVIG and B cell depleting agents

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

Other Intervention Names

IVIG; Mabthera; Velcade

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curie Ahn, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 26844479 (View on PubMed)

Other Identifiers

11374

Identifier Type: -

Identifier Source: org_study_id