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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
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, see Learn About Clinical Studies.

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
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 20, 2014