Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Roche Pharma AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assessing the impact of J12 curative treatment with rituximab (375 mg / m² on J5) based on a composite "TREATMENT FAILURE"
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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. |
|
| B | Placebo Comparator | 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of acute humoral rejection, investigators may propose an additional infusion of rituximab from J12, without patient withdrawn.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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MabThera | Drug | MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| "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 |
Not provided
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yvon LEBRANCHU | Contact | 02.47.47.82.29 | lebranchu@med.univ-tours.fr | |
| Estelle BOIVIN, CRA | Contact | 02.47.47.46.20 | boivin@med.univ-tours.fr |
| Name | Affiliation | Role |
|---|---|---|
| Yvon LEBRANCHU | University Hospital, Tours | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Henri Mondor | Recruiting | Paris | Créteil | 94010 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
| Physiological serum (Sodium Chloride, sodium citrate) | Drug | Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml) |
|
| Hospital | Active, not recruiting | Grenoble | La Tronche | 38700 | France |
| Hospital Bicêtre | Active, not recruiting | Paris | Le Kremlin Bicêtre | 94275 | France |
| Hospital Lyon Sud | Recruiting | Lyon | Pierre-Benite | 69495 | France |
|
| Hospital Nord | Active, not recruiting | Saint-Etienne | Saint Priez-en-Jarez | 42227 | France |
| Hospital Foch | Withdrawn | Paris | Suresnes | 92151 | France |
| Hospital Nancy-Brabois | Withdrawn | Nancy | Vandoeuvre-les-Nancy | 54511 | France |
| Hospital Sud | Recruiting | Amiens | 80054 | France |
|
| Hospital | Active, not recruiting | Angers | 49933 | France |
| Hospital Saint-Jacques | Recruiting | Besançon | 25030 | France |
|
| Hospital Pellegrin | Recruiting | Bordeaux | 33076 | France |
|
| Hospital | Active, not recruiting | Brest | 29609 | France |
| Hospital | Recruiting | Caen | 14033 | France |
|
| Hospital Gabriel Montpied | Active, not recruiting | Clermont-Ferrand | 63003 | France |
| Hospital Bocage | Active, not recruiting | Dijon | 21000 | France |
| Hospital Calmette | Recruiting | Lille | 59037 | France |
|
| Hospital Dupuytren | Recruiting | Limoges | 87042 | France |
|
| Hospital Edouard Herriot | Recruiting | Lyon | 69437 | France |
|
| Hospital Conception | Active, not recruiting | Marseille | 13385 | France |
| Hospital Lapeyronie | Recruiting | Montpellier | 34295 | France |
|
| Hospital Hôtel Dieu | Recruiting | Nantes | 44093 | France |
|
| Hospital Pasteur | Active, not recruiting | Nice | 06000 | France |
| Hospital Saint Louis | Not yet recruiting | Paris | 75000 | France |
|
| Hospital Tenon | Active, not recruiting | Paris | 75020 | France |
| Hospital Pitié-Salpêtrière | Recruiting | Paris | 75651 | France |
|
| Hospital Necker | Recruiting | Paris | 75743 | France |
|
| Hospital Milétrie Jean Bernard | Active, not recruiting | Poitiers | 86021 | France |
| Hospital Maison Blanche | Recruiting | Reims | 51092 | France |
|
| Hospital | Active, not recruiting | Rennes | 35033 | France |
| Hospital Bois-Guillaume | Recruiting | Rouen | 76231 | France |
|
| Hospital Civil | Active, not recruiting | Strasbourg | 67091 | France |
| Hospital Bretonneau | Recruiting | Tours | 37044 | France |
|
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D012965 | Sodium Chloride |
| D000077559 | Sodium Citrate |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D019343 | Citric Acid |
| D002951 | Citrates |
| D014233 | Tricarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided