---
title: Evaluation of Desensitization Protocols in HLA-incompatible Kidney-transplant Candidates
nct_id: NCT03507348
overall_status: TERMINATED
phase: NA
sponsor: University Hospital, Grenoble
study_type: INTERVENTIONAL
primary_condition: End-stage Renal Disease
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03507348.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03507348"
ct_last_update_post_date: 2020-03-30
last_seen_at: "2026-05-12T07:32:04.213Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of Desensitization Protocols in HLA-incompatible Kidney-transplant Candidates

**NCT ID:** [NCT03507348](https://clinicaltrials.gov/study/NCT03507348)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** investigateur decision
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 8
- **Lead Sponsor:** University Hospital, Grenoble
- **Conditions:** End-stage Renal Disease, Kidney Transplantation, Hla-incompatible Kidney Transplant Candidates
- **Start Date:** 2018-07-01
- **Completion Date:** 2019-11-21
- **CT.gov Last Update:** 2020-03-30

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Desensitization with Tocilizumab and rituximab (MFI >15000)** (OTHER)
- **Desensitization with Rituximab only (MFI<15000)** (OTHER)

## Interventions

- **visits of tocilizumab injection (every 4 weeks, up to 5 visits)** (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** (DRUG) — Rituximab 375 mg/m2 at Day-30
- **Rituximab 375 mg/m2 at Day-15 (only for donors living)** (DRUG) — Rituximab 375 mg/m2 at Day-15
- **Transplant Day-0** (OTHER) — TRANSPLANTATION

## Primary Outcomes

- **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)_ — Decrease of MFI for highest donor-specific alloantibody (DSA) between start and end of desensitization for every patient in each category

## Secondary Outcomes

- **Desensitization efficacy with regards to DSA decrease and kidney transplantation** _(time frame: Day-198, at day-30 Graft, at day-15, at day0 of Graft,)_
- **impairment of DSA synthesis** _(time frame: Day-198, at day-30 Graft, at day-15, at day0 of Graft,)_
- **Impairment of immune response** _(time frame: Day-198, at day-30 Graft, at day-15, at day0 of Graft,)_
- **Incidence of treatment desensitization protocols, emergent adverse events (safety and Tolerability)** _(time frame: Day-198, at day-30 Graft, at day-15)_

## Locations (1)

- Grenoble Alpes University Hospital, La Tronche, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.grenoble alpes university hospital|la tronche||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03507348.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03507348*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*