Evaluation of Desensitization Protocols in HLA-incompatible Kidney-transplant Candidates

Sponsor
University Hospital, Grenoble
Study ID
NCT03507348
Status
Terminated

Conditions

  • End-stage Renal Disease
  • Hla-incompatible Kidney Transplant Candidates
  • Kidney Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Kidney transplantation is the best renal-replacement in the setting of end-stage renal disease. However, some transplant candidates have developed anti-HLA alloantibodies (human leukocyte antigen). When they are numerous and when their strength assessed by mean fluorescence intensity (MFI) is high it is very complicated to find-out a suitable kidney allograft against which the recipient has a negative cross-match. In such a case the only hope for the patient is desensitization therapy, whereby the treatment will decrease anti-HLA alloantibodies below a threshold, i.e. MFI \< 3,000, enabling kidney transplantation without risking antibody-mediated rejection. Desensitization relies on i) apheresis technics in order to withdraw circulating anti-HLA antibodies, and ii) immunosuppression, i.e. rituximab or tocilizumab, targeting B-lymphocytes, and tacrolimus/mycophenolic acid/steroids targeting T-cells. The type of apheresis is guided by the pre-desensitization MFI of anti-HLA alloantibodies, e.g. double filtration plasmapheresis or semispecific immunoadsorption. Likely the choice between rituximab and tocilizumab depends also on predesensitization anti-HLA antibody MFIs. At the end of the desensitization process, the patient will be able to get a kidney transplant either from a live-donor or from a deceased donor.

Key Dates

Start date
Jul 1, 2018
Status verified
Mar 2020
Primary completion
Nov 21, 2019
Completion
Nov 21, 2019

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Desensitization with Tocilizumab and rituximab (MFI >15000)
  • Other: Desensitization with Rituximab only (MFI<15000)

Primary Outcome Measure

Description of the results of the strategy of desensitization in patients who will access to kidney transplantation from deceased or living donors. [ Time Frame: at day 1 start of desensitization, at day 0 of Graft ]

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