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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-11-21

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Desensitization with Tocilizumab and rituximab (MFI >15000)

Group Type OTHER

visits of tocilizumab injection (every 4 weeks, up to 5 visits)

Intervention Type DRUG

every 4 weeks, up to 5 visits (D-170, D-142, D-114, D-86, D-58).

Rituximab 375 mg/m2 at Day-30

Intervention Type DRUG

Rituximab 375 mg/m2 at Day-30

Rituximab 375 mg/m2 at Day-15 (only for donors living)

Intervention Type DRUG

Rituximab 375 mg/m2 at Day-15

Transplant Day-0

Intervention Type OTHER

TRANSPLANTATION

Desensitization with Rituximab only (MFI<15000)

Group Type OTHER

Rituximab 375 mg/m2 at Day-30

Intervention Type DRUG

Rituximab 375 mg/m2 at Day-30

Rituximab 375 mg/m2 at Day-15 (only for donors living)

Intervention Type DRUG

Rituximab 375 mg/m2 at Day-15

Transplant Day-0

Intervention Type OTHER

TRANSPLANTATION

Interventions

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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).

Intervention Type DRUG

Rituximab 375 mg/m2 at Day-30

Intervention Type DRUG

Rituximab 375 mg/m2 at Day-15 (only for donors living)

Rituximab 375 mg/m2 at Day-15

Intervention Type DRUG

Transplant Day-0

TRANSPLANTATION

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients on the kidney transplant list, waiting for a first or repeat transplant
* Presence of anti HLA antibodies either class I and/or II
* Sensitized against a potential living donor or have been on the waiting list for at least 3 years and having no potential live-donor
* Patients eligible for desensitization will receive either rituximab alone, or rituximab plus apheresis, or tocilizumab before rituximab
* Normal recent (\<6 months) cardiac workup
* Vaccinated against pneumococcus and meningococcus B and C
* Willingness of the patient to undergo the desensitization process and Express consent of the patient
* for women of childbearing age, effective contraception or abstinence
* Affiliated to a social security scheme or of such a scheme

Exclusion Criteria

* Active underlying infections or neoplasia
* Pregnant women, parturient or breastfeeding
* Subject in exclusion period of another study
* Subject under administrative or judicial control
* Subject who cannot be contacted in an emergency
* Rituximab contra indication: hypersensitivity (to active substance or murine protein), active and severe infections, patients in a severely immunocompromised state, severe heart failure or severe, uncontrolled cardiac disease.
* Tocilizumab contra indication: hypersensitivity, active and severe infections. Apheresis contra indication: active and severe infection, untreated or instable coagulation disorders, unstable coronary disease, recent stroke, hemodynamic instability.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No