Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation
NCT ID: NCT01350882
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2008-10-31
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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.
MabThera
MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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.
Physiological serum : sodium chloride, sodium citrate
Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
Interventions
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MabThera
MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
Physiological serum : sodium chloride, sodium citrate
Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Yvon LEBRANCHU
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Tours
Locations
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Hospital Henri Mondor
Paris, Créteil, France
Hospital
Grenoble, La Tronche, France
Hospital Bicêtre
Paris, Le Kremlin Bicêtre, France
Hospital Lyon Sud
Lyon, Pierre-Benite, France
Hospital Nord
Saint-Etienne, Saint Priez-en-Jarez, France
Hospital Sud
Amiens, , France
Hospital
Angers, , France
Hospital Saint-Jacques
Besançon, , France
Hospital Pellegrin
Bordeaux, , France
Hospital
Brest, , France
Hospital
Caen, , France
Hospital Gabriel Montpied
Clermont-Ferrand, , France
Hospital Bocage
Dijon, , France
Hospital Calmette
Lille, , France
Hospital Dupuytren
Limoges, , France
Hospital Edouard Herriot
Lyon, , France
Hospital Conception
Marseille, , France
Hospital Lapeyronie
Montpellier, , France
Hospital Hôtel Dieu
Nantes, , France
Hospital Pasteur
Nice, , France
Hospital Saint Louis
Paris, , France
Hospital Tenon
Paris, , France
Hospital Pitié-Salpêtrière
Paris, , France
Hospital Necker
Paris, , France
Hospital Milétrie Jean Bernard
Poitiers, , France
Hospital Maison Blanche
Reims, , France
Hospital
Rennes, , France
Hospital Bois-Guillaume
Rouen, , France
Hospital Civil
Strasbourg, , France
Hospital Bretonneau
Tours, , France
Countries
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References
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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.
Other Identifiers
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PHRN07-YL RITUXERAH
Identifier Type: -
Identifier Source: org_study_id