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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University Hospital, Tours.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01350882
First received: February 4, 2010
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Humoral Rejection in Kidney Transplantation
Drug: MabThera
Drug: Physiological serum : sodium chloride, sodium citrate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • "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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: October 2008
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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 Name: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350882

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

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01350882     History of Changes
Other Study ID Numbers: PHRN07-YL RITUXERAH
Study First Received: February 4, 2010
Last Updated: December 22, 2011
Health Authority: France: Afssaps Health Products Safety Agency

Keywords provided by University Hospital, Tours:
kidney transplantation
acute humoral rejection
rituximab

Additional relevant MeSH terms:
Citric Acid
Rituximab
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014