Can a single drug save rejected kidneys? new trial investigates
NCT ID NCT01350882
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the drug rituximab to standard care could stop acute rejection in kidney transplant patients. 40 adults who had a kidney transplant within the past year and showed signs of acute humoral rejection took part. The main goal was to see if rituximab could prevent graft loss or improve kidney function by day 12.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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40 people
The number who actually took part.
- Started
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Oct 2008
- Finished
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Oct 2013
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hospital
Grenoble, La Tronche, 38700, France
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Hospital
Angers, 49933, France
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Hospital
Brest, 29609, France
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Hospital
Caen, 14033, France
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Hospital
Rennes, 35033, France
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Hospital Bicêtre
Paris, Le Kremlin Bicêtre, 94275, France
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Hospital Bocage
Dijon, 21000, France
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Hospital Bois-Guillaume
Rouen, 76231, France
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Hospital Bretonneau
Tours, 37044, France
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Hospital Calmette
Lille, 59037, France
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Hospital Civil
Strasbourg, 67091, France
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Hospital Conception
Marseille, 13385, France
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Hospital Dupuytren
Limoges, 87042, France
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Hospital Edouard Herriot
Lyon, 69437, France
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Hospital Gabriel Montpied
Clermont-Ferrand, 63003, France
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Hospital Henri Mondor
Paris, Créteil, 94010, France
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Hospital Hôtel Dieu
Nantes, 44093, France
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Hospital Lapeyronie
Montpellier, 34295, France
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Hospital Lyon Sud
Lyon, Pierre-Benite, 69495, France
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Hospital Maison Blanche
Reims, 51092, France
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Hospital Milétrie Jean Bernard
Poitiers, 86021, France
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Hospital Necker
Paris, 75743, France
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Hospital Nord
Saint-Etienne, Saint Priez-en-Jarez, 42227, France
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Hospital Pasteur
Nice, 06000, France
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Hospital Pellegrin
Bordeaux, 33076, France
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Hospital Pitié-Salpêtrière
Paris, 75651, France
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Hospital Saint Louis
Paris, 75000, France
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Hospital Saint-Jacques
Besançon, 25030, France
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Hospital Sud
Amiens, 80054, France
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Hospital Tenon
Paris, 75020, France