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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01502267
Recruitment Status : Unknown
Verified January 2012 by Seoul National University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 30, 2011
Last Update Posted : January 6, 2012
Roche Pharma AG
Information provided by (Responsible Party):
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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients
Study Start Date : January 2010
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: January 6, 2012
Last Verified: January 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