Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
2 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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