MedTrace Logo

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

NCT03507348 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-03-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2019-11-21
Completion
2019-11-21

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507348 on ClinicalTrials.gov