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

Graft Rejection Clinical Trial

— RITUX-ERAH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01066689
• Other study ID #: PHRN07-YL RITUX-ERAH
• Status: Recruiting
• Phase: Phase 3
• First received: February 3, 2010
• Last updated: February 9, 2010
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: February 2010
• Source: University Hospital, Tours
• Contact: Yvon LEBRANCHU
• Phone: 02.47.47.82.29
• Email: lebranchu[@]med.univ-tours.fr
• Is FDA regulated: No
• Health authority: France: Afssaps Health Products Safety Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Rejection

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
France	Hospital Sud	Amiens
France	Hospital	Angers
France	Hospital Saint-Jacques	Besancon
France	Hospital Pellegrin	Bordeaux
France	Hospital	Brest
France	Hospital	Caen
France	Hospital Gabriel Montpied	Clermont-ferrand
France	Hospital Bocage	Dijon
France	Hospital	Grenoble	La Tronche
France	Hospital Calmette	Lille
France	Hospital Dupuytren	Limoges
France	Hospital Edouard Herriot	Lyon
France	Hospital Lyon Sud	Lyon	Pierre-Benite
France	Hospital Conception	Marseille
France	Hospital Lapeyronie	Montpellier
France	Hospital Nancy-Brabois	Nancy	Vandoeuvre-les-Nancy
France	Hospital Hôtel Dieu	Nantes
France	Hospital Pasteur	Nice
France	Hospital Bicêtre	Paris	Le Kremlin Bicêtre
France	Hospital Foch	Paris	Suresnes
France	Hospital Henri Mondor	Paris	Créteil
France	Hospital Necker	Paris
France	Hospital Pitié-Salpêtrière	Paris
France	Hospital Saint Louis	Paris
France	Hospital Tenon	Paris
France	Hospital Milétrie Jean Bernard	Poitiers
France	Hospital Maison Blanche	Reims
France	Hospital	Rennes
France	Hospital Bois-Guillaume	Rouen
France	Hospital Nord	Saint-Etienne	Saint Priez-en-Jarez
France	Hospital Civil	Strasbourg
France	Hospital Bretonneau	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Tours	Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"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	Yes