Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation (RITUX-ERAH)

February 7, 2018 updated by: University Hospital, Tours

Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation

Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • Hospital Sud
      • Angers, France, 49933
        • Hospital
      • Besancon, France, 25030
        • Hospital Saint-Jacques
      • Bordeaux, France, 33076
        • Hospital Pellegrin
      • Brest, France, 29609
        • Hospital
      • Caen, France, 14033
        • Hospital
      • Clermont-ferrand, France, 63003
        • Hospital Gabriel Montpied
      • Dijon, France, 21000
        • Hospital Bocage
      • Lille, France, 59037
        • Hospital Calmette
      • Limoges, France, 87042
        • Hospital Dupuytren
      • Lyon, France, 69437
        • Hospital Edouard Herriot
      • Marseille, France, 13385
        • Hospital Conception
      • Montpellier, France, 34295
        • Hospital Lapeyronie
      • Nantes, France, 44093
        • Hospital Hôtel Dieu
      • Nice, France, 06000
        • Hospital Pasteur
      • Paris, France, 75020
        • Hospital Tenon
      • Paris, France, 75000
        • Hospital Saint Louis
      • Paris, France, 75651
        • Hospital Pitie-Salpetriere
      • Paris, France, 75743
        • Hospital Necker
      • Poitiers, France, 86021
        • Hospital Milétrie Jean Bernard
      • Reims, France, 51092
        • Hospital Maison Blanche
      • Rennes, France, 35033
        • Hospital
      • Rouen, France, 76231
        • Hospital Bois-Guillaume
      • Strasbourg, France, 67091
        • Hospital Civil
      • Tours, France, 37044
        • Hospital Bretonneau
    • Créteil
      • Paris, Créteil, France, 94010
        • Hospital Henri Mondor
    • La Tronche
      • Grenoble, La Tronche, France, 38700
        • Hospital
    • Le Kremlin Bicêtre
      • Paris, Le Kremlin Bicêtre, France, 94275
        • Hospital BICETRE
    • Pierre-Benite
      • Lyon, Pierre-Benite, France, 69495
        • Hospital Lyon Sud
    • Saint Priez-en-Jarez
      • Saint-Etienne, Saint Priez-en-Jarez, France, 42227
        • Hospital Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient adult male or female (age 18 years), kidney transplantation for less than one year (transplant from a living donor or deceased), with acute humoral rejection defined by :
  • The deterioration of renal function assessed by serum creatinine increase of more than 20% compared to the best value, OR
  • In the first 28 days after transplantation, no significant creatinine decrease, AND

  • At least 2 of the 3 following criteria:

    • tissue damage such as (a) acute tubular necrosis, (b) presence of monocytes or granulocytes in the CPT and / or glomeruli and / or capillary thrombosis, (c) intimal arteritis / fibrinoid necrosis
    • C4d level of CPT and / or presence of Ig or complement in lesions of fibrinoid necrosis
    • Presence of HLA antibodies directed against the donor. Patient having given his written consent to participate in the clinical trial.

Exclusion Criteria:

  • Pregnant or lactating
  • Women during their reproductive years without effective contraception,
  • A patient with multiple organ transplants,
  • Patients with clinically active infection by HCV uncontrolled
  • Patients with active infection, or suspected of infection by HIV or HBV, and tuberculosis,
  • Patients with heart failure class IV (NYHA) cardiac disease or uncontrolled
  • Patients for whom vaccination is scheduled,
  • Patient with disabilities did not allow an understanding of the requirements of the test
  • Patient in safeguarding justice, guardianship or trusteeship,
  • Patient with cons-indication to rituximab (known hypersensitivity to any component or murine protein)
  • Patient had previously received rituximab within 3 months before inclusion
  • Patient participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Patients randomized into the arm blind A. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab.
Drug: MabThera
MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
Other Names:
  • rituximab
Placebo Comparator: B
Patients randomized into the arm blind B. Rituximab is allowed as additional treatment from J12, within the limit of 2 infusions of rituximab. In case of insufficient efficacy of the treatment of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn. In this case (2nd infusion effective in group A and 1st infusion effective group B), a additional consultation (CS) will be provided as part of the study 7 days after infusion. In case of insufficient efficacy of the treatment,in fairness to care for patients between the 2 treatment groups, the investigators may propose to a 3rd infusion patients in group B (2nd infusion effective for this group). To prevent patients from group A will receive a 3rd infusion of rituximab, unblinding will be applied in this case by the investigator before the administration of additional treatment with rituximab.
Drug: Physiological serum : sodium chloride, sodium citrate
Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
"Treatment failure" grouping at J12: - Loss of graft - Whether improving renal function (defined by the absence of a decrease in creatinine of at least 30% compared to the maximum serum creatinine reached at the RAH)
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: Yvon LEBRANCHU, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

May 9, 2011

First Posted (Estimate)

May 10, 2011

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 7, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRN07-YL RITUXERAH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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