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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01502267
First received: December 24, 2011
Last updated: January 5, 2012
Last verified: January 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in anti-HLA alloantibodies [ Time Frame: 1year ] [ Designated as safety issue: No ]
  • Renal allograft survival [ Time Frame: from one to five year ] [ Designated as safety issue: No ]
    graft and patient survival

  • The number of serious complication [ Time Frame: from one to five year ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502267

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

Additional Information:
No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01502267     History of Changes
Other Study ID Numbers: 11374
Study First Received: December 24, 2011
Last Updated: January 5, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014