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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Seoul National University Hospital.
Recruitment status was:  Enrolling by invitation
Roche Pharma AG
Information provided by (Responsible Party):
Seoul National University Hospital Identifier:
First received: December 24, 2011
Last updated: January 5, 2012
Last verified: January 2012
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.

Condition Intervention Phase
End Stage Renal Disease
Drug: High dose IVIG and B cell depleting agents
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients

Resource links provided by NLM:

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The rates of kidney transplantation [ Time Frame: from one to five years ]

Secondary Outcome Measures:
  • Reduction in anti-HLA alloantibodies [ Time Frame: 1year ]
  • Renal allograft survival [ Time Frame: from one to five year ]
    graft and patient survival

  • The number of serious complication [ Time Frame: from one to five year ]

Estimated Enrollment: 2
Study Start Date: January 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Group 1
This group will not receive IVIG and B cell depleting agents
Experimental: Group 2
This group will receive IVIG and B cell depleting agents
Drug: 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)
Other Names:
  • IVIG
  • Mabthera
  • Velcade

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01502267

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-799
Sponsors and Collaborators
Seoul National University Hospital
Roche Pharma AG
Principal Investigator: Curie Ahn, MD Seoul National University Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seoul National University Hospital Identifier: NCT01502267     History of Changes
Other Study ID Numbers: 11374
Study First Received: December 24, 2011
Last Updated: January 5, 2012

Keywords provided by Seoul National University Hospital:
Waiting list
Deceased donor kidney transplantation
anti HLA antibody

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases processed this record on May 25, 2017