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Can a single drug save rejected kidneys? new trial investigates

NCT ID NCT01350882

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

40 people

The number who actually took part.

Started

Oct 2008

Finished

Oct 2013

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Hospital

    Grenoble, La Tronche, 38700, France

  • Hospital

    Angers, 49933, France

  • Hospital

    Brest, 29609, France

  • Hospital

    Caen, 14033, France

  • Hospital

    Rennes, 35033, France

  • Hospital Bicêtre

    Paris, Le Kremlin Bicêtre, 94275, France

  • Hospital Bocage

    Dijon, 21000, France

  • Hospital Bois-Guillaume

    Rouen, 76231, France

  • Hospital Bretonneau

    Tours, 37044, France

  • Hospital Calmette

    Lille, 59037, France

  • Hospital Civil

    Strasbourg, 67091, France

  • Hospital Conception

    Marseille, 13385, France

  • Hospital Dupuytren

    Limoges, 87042, France

  • Hospital Edouard Herriot

    Lyon, 69437, France

  • Hospital Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • Hospital Henri Mondor

    Paris, Créteil, 94010, France

  • Hospital Hôtel Dieu

    Nantes, 44093, France

  • Hospital Lapeyronie

    Montpellier, 34295, France

  • Hospital Lyon Sud

    Lyon, Pierre-Benite, 69495, France

  • Hospital Maison Blanche

    Reims, 51092, France

  • Hospital Milétrie Jean Bernard

    Poitiers, 86021, France

  • Hospital Necker

    Paris, 75743, France

  • Hospital Nord

    Saint-Etienne, Saint Priez-en-Jarez, 42227, France

  • Hospital Pasteur

    Nice, 06000, France

  • Hospital Pellegrin

    Bordeaux, 33076, France

  • Hospital Pitié-Salpêtrière

    Paris, 75651, France

  • Hospital Saint Louis

    Paris, 75000, France

  • Hospital Saint-Jacques

    Besançon, 25030, France

  • Hospital Sud

    Amiens, 80054, France

  • Hospital Tenon

    Paris, 75020, France