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

February 4, 2010
December 22, 2011
October 2008
October 2012   (final data collection date for primary outcome measure)
"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 ]
Same as current
Complete list of historical versions of study NCT01350882 on ClinicalTrials.gov Archive Site
Not Provided
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Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
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"

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Humoral Rejection in Kidney Transplantation
  • Drug: MabThera
    MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
    Other Name: 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)
  • 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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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.
    Intervention: Drug: MabThera
  • 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.
    Intervention: Drug: Physiological serum : sodium chloride, sodium citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01350882
PHRN07-YL RITUXERAH
No
University Hospital, Tours
University Hospital, Tours
Roche Pharma AG
Principal Investigator: Yvon LEBRANCHU University Hospital, Tours
University Hospital, Tours
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP