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OpenTrials
Completed

NCT Number: NCT01350882

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"

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Henri Mondor, Paris, Créteil, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mabthera

Drug

MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2

Other names: rituximab

Physiological serum : sodium chloride, sodium citrate

Drug

Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)

Primary outcomes

  1. "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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Acronym: RITUX-ERAH

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
May 10, 2011
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.