NCT03507348

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University Hospital, Grenoble · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	visits of tocilizumab injection (every 4 weeks, up to 5 visits)	every 4 weeks, up to 5 visits (D-170, D-142, D-114, D-86, D-58).
DRUG	Rituximab 375 mg/m2 at Day-30	Rituximab 375 mg/m2 at Day-30
DRUG	Rituximab 375 mg/m2 at Day-15 (only for donors living)	Rituximab 375 mg/m2 at Day-15
OTHER	Transplant Day-0	TRANSPLANTATION

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-11-21
• Completion: 2019-11-21
• First posted: 2018-04-25
• Last updated: 2020-03-30

Locations

1 site across 1 country: France