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 February 2010 by University Hospital, Tours.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Tours
Collaborator:
Roche Pharma AG
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01066689
First received: February 3, 2010
Last updated: February 9, 2010
Last verified: February 2010
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Purpose
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"
| Condition | Intervention | Phase |
|---|---|---|
|
Graft Rejection |
Drug: MabThera Drug: Physiological serum (Sodium Chloride, sodium citrate) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase III Study of Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal Transplantation. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Tours:
Primary Outcome Measures:
- "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 ]
| Estimated Enrollment: | 64 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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.
|
Drug: MabThera
MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
Other Name: rituximab
|
|
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.
|
Drug: Physiological serum (Sodium Chloride, sodium citrate)
Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066689
Contacts
| Contact: Yvon LEBRANCHU | 02.47.47.82.29 | lebranchu@med.univ-tours.fr |
| Contact: Estelle BOIVIN, CRA | 02.47.47.46.20 | boivin@med.univ-tours.fr |
Locations
| France | |
| Hospital Henri Mondor | Recruiting |
| Paris, Créteil, France, 94010 | |
| Sub-Investigator: Philippe LANG | |
| Hospital | Active, not recruiting |
| Grenoble, La Tronche, France, 38700 | |
| Hospital Bicêtre | Active, not recruiting |
| Paris, Le Kremlin Bicêtre, France, 94275 | |
| Hospital Lyon Sud | Recruiting |
| Lyon, Pierre-Benite, France, 69495 | |
| Sub-Investigator: Claire POUTEIL-NOBLE | |
| Hospital Nord | Active, not recruiting |
| Saint-Etienne, Saint Priez-en-Jarez, France, 42227 | |
| Hospital Foch | Withdrawn |
| Paris, Suresnes, France, 92151 | |
| Hospital Nancy-Brabois | Withdrawn |
| Nancy, Vandoeuvre-les-Nancy, France, 54511 | |
| Hospital Sud | Recruiting |
| Amiens, France, 80054 | |
| Sub-Investigator: Pierre-François WESTEEL | |
| Hospital | Active, not recruiting |
| Angers, France, 49933 | |
| Hospital Saint-Jacques | Recruiting |
| Besancon, France, 25030 | |
| Sub-Investigator: Didier DUCLOUX | |
| Hospital Pellegrin | Recruiting |
| Bordeaux, France, 33076 | |
| Sub-Investigator: Pierre MERVILLE | |
| Hospital | Active, not recruiting |
| Brest, France, 29609 | |
| Hospital | Recruiting |
| Caen, France, 14033 | |
| Sub-Investigator: Bruno HURAULT DE LIGNY | |
| Hospital Gabriel Montpied | Active, not recruiting |
| Clermont-ferrand, France, 63003 | |
| Hospital Bocage | Active, not recruiting |
| Dijon, France, 21000 | |
| Hospital Calmette | Recruiting |
| Lille, France, 59037 | |
| Sub-Investigator: Marc HAZZAN | |
| Hospital Dupuytren | Recruiting |
| Limoges, France, 87042 | |
| Sub-Investigator: Jean-Philippe REROLLE | |
| Hospital Edouard Herriot | Recruiting |
| Lyon, France, 69437 | |
| Sub-Investigator: Emmanuel MORELON | |
| Hospital Conception | Active, not recruiting |
| Marseille, France, 13385 | |
| Hospital Lapeyronie | Recruiting |
| Montpellier, France, 34295 | |
| Sub-Investigator: Georges MOURAD | |
| Hospital Hôtel Dieu | Recruiting |
| Nantes, France, 44093 | |
| Sub-Investigator: Gilles BLANCHO | |
| Hospital Pasteur | Active, not recruiting |
| Nice, France, 06000 | |
| Hospital Necker | Recruiting |
| Paris, France, 75743 | |
| Sub-Investigator: Eric THERVET | |
| Hospital Saint Louis | Not yet recruiting |
| Paris, France, 75000 | |
| Sub-Investigator: Denis GLOTZ | |
| Hospital Pitié-Salpêtrière | Recruiting |
| Paris, France, 75651 | |
| Sub-Investigator: Benoît BARROU | |
| Hospital Tenon | Active, not recruiting |
| Paris, France, 75020 | |
| Hospital Milétrie Jean Bernard | Active, not recruiting |
| Poitiers, France, 86021 | |
| Hospital Maison Blanche | Recruiting |
| Reims, France, 51092 | |
| Sub-Investigator: Olivier TOUPANCE | |
| Hospital | Active, not recruiting |
| Rennes, France, 35033 | |
| Hospital Bois-Guillaume | Recruiting |
| Rouen, France, 76231 | |
| Sub-Investigator: Stéphane BARBIER | |
| Hospital Civil | Active, not recruiting |
| Strasbourg, France, 67091 | |
| Hospital Bretonneau | Recruiting |
| Tours, France, 37044 | |
| Principal Investigator: Yvon LEBRANCHU | |
Sponsors and Collaborators
University Hospital, Tours
Roche Pharma AG
Investigators
| Principal Investigator: | Yvon LEBRANCHU | University Hospital, Tours |
More Information
No publications provided
| Responsible Party: | Jocelyne MARLIERE, University Hospital, Tours |
| ClinicalTrials.gov Identifier: | NCT01066689 History of Changes |
| Other Study ID Numbers: | PHRN07-YL RITUX-ERAH |
| Study First Received: | February 3, 2010 |
| Last Updated: | February 9, 2010 |
| Health Authority: | France: Afssaps Health Products Safety Agency |
Keywords provided by University Hospital, Tours:
|
kidney transplantation, acute humoral rejection, rituximab |
Additional relevant MeSH terms:
|
Citric Acid Rituximab Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
Chelating Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013