Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
RITUX-ERAH
Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
1 other identifier
interventional
40
1 country
30
Brief Summary
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
Typical duration for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedDecember 26, 2025
February 1, 2018
4 years
February 4, 2010
December 18, 2025
Conditions
Keywords
Outcome Measures
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)
one year
Study Arms (2)
A
EXPERIMENTALPatients 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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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.
B
PLACEBO COMPARATORPatients 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.
Interventions
Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 participation in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Tourslead
- Roche Pharma AGcollaborator
Study Sites (30)
Hospital Henri Mondor
Paris, Créteil, 94010, France
Hospital
Grenoble, La Tronche, 38700, France
Hospital Bicêtre
Paris, Le Kremlin Bicêtre, 94275, France
Hospital Lyon Sud
Lyon, Pierre-Benite, 69495, France
Hospital Nord
Saint-Etienne, Saint Priez-en-Jarez, 42227, France
Hospital Sud
Amiens, 80054, France
Hospital
Angers, 49933, France
Hospital Saint-Jacques
Besançon, 25030, France
Hospital Pellegrin
Bordeaux, 33076, France
Hospital
Brest, 29609, France
Hospital
Caen, 14033, France
Hospital Gabriel Montpied
Clermont-Ferrand, 63003, France
Hospital Bocage
Dijon, 21000, France
Hospital Calmette
Lille, 59037, France
Hospital Dupuytren
Limoges, 87042, France
Hospital Edouard Herriot
Lyon, 69437, France
Hospital Conception
Marseille, 13385, France
Hospital Lapeyronie
Montpellier, 34295, France
Hospital Hôtel Dieu
Nantes, 44093, France
Hospital Pasteur
Nice, 06000, France
Hospital Saint Louis
Paris, 75000, France
Hospital Tenon
Paris, 75020, France
Hospital Pitié-Salpêtrière
Paris, 75651, France
Hospital Necker
Paris, 75743, France
Hospital Milétrie Jean Bernard
Poitiers, 86021, France
Hospital Maison Blanche
Reims, 51092, France
Hospital
Rennes, 35033, France
Hospital Bois-Guillaume
Rouen, 76231, France
Hospital Civil
Strasbourg, 67091, France
Hospital Bretonneau
Tours, 37044, France
Related Publications (1)
Sautenet B, Blancho G, Buchler M, Morelon E, Toupance O, Barrou B, Ducloux D, Chatelet V, Moulin B, Freguin C, Hazzan M, Lang P, Legendre C, Merville P, Mourad G, Mousson C, Pouteil-Noble C, Purgus R, Rerolle JP, Sayegh J, Westeel PF, Zaoui P, Boivin H, Le Gouge A, Lebranchu Y. One-year Results of the Effects of Rituximab on Acute Antibody-Mediated Rejection in Renal Transplantation: RITUX ERAH, a Multicenter Double-blind Randomized Placebo-controlled Trial. Transplantation. 2016 Feb;100(2):391-9. doi: 10.1097/TP.0000000000000958.
PMID: 26555944RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yvon LEBRANCHU
University Hospital, Tours
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2010
First Posted
May 10, 2011
Study Start
October 1, 2008
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 26, 2025
Record last verified: 2018-02