Status:
UNKNOWN
Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Roche Pharma AG
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 usi...
Eligibility Criteria
Inclusion
- Age ≥ 18
- patients who are on the waiting list more than 4 years
- PRA I or II \> 50%
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01502267
Start Date
January 1 2010
End Date
January 1 2016
Last Update
January 6 2012
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-799