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Kidney failure patients may ditch immune drugs in landmark trial

NCT ID NCT03323476

Disease control Sponsor: Centre Hospitalier Departemental Vendee Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether people with ANCA vasculitis who have reached end-stage kidney disease can safely stop taking immunosuppressive medications. The goal is to see if stopping these drugs lowers the risk of serious infections and other side effects without causing dangerous disease flare-ups. About 136 adults will be randomly assigned to either stop or continue their maintenance immunosuppression, and researchers will track severe events like infections, relapses, and death over two years.

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

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2018

Expected to finish

Mar 2031

An estimate. End dates often move.

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 to 90 years

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: * Age ≥ 18 years and ≤ 90 years * Patients affected by a GPA or MPA AAV with a renal injury * Patients with initial manifestation or relapse of AAV * Patients with ESRD, defined by a glomerular filtration rate estimated using the MDRD formula ≤15 mL/min or requirement for dialysis for more than 60 days * Patients with ESRD on native kidney * Patients who gave written informed consent for participation in the study * Patients with affiliation to the French social security system Exclusion Criteria: * Patients who experienced severe extra-renal disease due to AAV (intra-alveolar haemorrhage with blood oxygen saturation ≤ 85% on room air or ventilated, or central nervous system disease) in the last 12 months prior to inclusion * Patients with AAV-associated renal involvement (with active inflammatory lesions in kidney biopsy) diagnosed less than three months and receiving induction treatment with cyclophosphamide or rituximab or diagnosed less than 45 days for patients who have receveid only treatment based on steroid infusion without cyclophosphamide or rituximab * Patients who received maintenance immunosuppressive treatment for more than 6 months during the last 12 months * Patient with a diagnosis of vasculitis other than GPA or MPA * Patients with another immunologic systemic disease (Lupus, sarcoidosis…) Patients with active HCV, HBV or HIV infection * Patients with a history of serious viral infection (CMV, HHV8, etc.) in the 2 months prior to the inclusion, or severe uncontrolled chronic infection (tuberculosis, etc.) * Patients with uncontrolled cancer or hemopathy * Kidney transplant patient * Inability to understand and sign the informed consent * Pregnant women. * Women of child-bearing age without effective method of contraception * Age \< 18 years or \> 90 years. * Patients under guardianship or trusteeship.

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis chronic kidney disease end stage renal failure granulomatosis with polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-neutrophil cytoplasmic antibody-associated vasculitis End-stage renal disease

Contacts and locations

Locations

  • APHP - Henri Mondor

    Paris, France

  • APHP Ambroise Paré

    Boulogne-Billancourt, France

  • AUB Santé

    Avranches, France

  • AUB Santé - Lorient

    Lorient, France

  • AUB Santé - Rennes

    Rennes, France

  • Aphp - Bichat

    Paris, France

  • Aphp - Hegp

    Paris, France

  • CHI Eure Seine

    Évreux, France

  • CHRU Besançon

    Besançon, France

  • CHRU Bretonneau

    Tours, France

  • CHRU Lille

    Lille, France

  • CHU Angers

    Angers, France

  • CHU Kremlin - Bicêtre

    Paris, France

  • CHU Toulouse

    Toulouse, France

  • CHU de Nimes

    Nîmes, France

  • Centre ECHO - Le Mans

    Le Mans, France

  • Centre Hospitalier ARRAS

    Arras, France

  • Centre Hospitalier Alpes Léman

    Sallanches, France

  • Centre Hospitalier Angoulême

    Angoulême, France

  • Centre Hospitalier Avignon

    Avignon, France

  • Centre Hospitalier Boulogne sur Mer

    Boulogne-sur-Mer, France

  • Centre Hospitalier Bretagne Atlantique

    Vannes, France

  • Centre Hospitalier Chartres

    Chartres, France

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85925, France

  • Centre Hospitalier Emile ROUX

    Le Puy-en-Velay, France

  • Centre Hospitalier La Rochelle

    La Rochelle, France

  • Centre Hospitalier Le Mans

    Le Mans, France

  • Centre Hospitalier Lyon Sud

    Lyon, France

  • Centre Hospitalier Quimper

    Quimper, France

  • Centre Hospitalier René Dubois - Pontoise

    Cergy-Pontoise, France

  • Centre Hospitalier Saint Brieuc

    Saint-Brieuc, France

  • Centre Hospitalier Saint-Malo

    St-Malo, France

  • Centre Hospitalier Saint-Nazaire

    Saint-Nazaire, France

  • Centre Hospitalier Universitaire Amiens

    Amiens, France

  • Centre Hospitalier Universitaire Bordeaux

    Bordeaux, France

  • Centre Hospitalier Universitaire Dupuytren

    Limoges, France

  • Centre Hospitalier Universitaire G. Montpied

    Clermont-Ferrand, France

  • Centre Hospitalier Universitaire Grenoble

    Grenoble, France

  • Centre Hospitalier Universitaire Lapeyronie

    Montpellier, France

  • Centre Hospitalier Universitaire Nice

    Nice, France

  • Centre Hospitalier Universitaire Poitiers

    Poitiers, France

  • Centre Hospitalier Universitaire Rennes

    Rennes, France

  • Centre Hospitalier Universitaire Rouen

    Rouen, France

  • Centre Hospitalier Universitaire Saint Etienne

    Saint-Etienne, France

  • Centre Hospitalier Universitaire Strasbourg

    Strasbourg, France

  • Centre Hospitalier Universitaire de Brest

    Brest, France

  • Centre Hospitalier Universitaire de Dijon

    Dijon, France

  • Centre Hospitalier Universitaire de Nantes

    Nantes, France

  • Centre Hospitalier Valenciennes

    Valenciennes, France

  • Centre Hospitalier de Mont de Marsan

    Mont-de-Marsan, France

  • Clinique Saint Exupéry

    Toulouse, France

  • GHR Mulhouse Sud Alsace

    Mulhouse, France

  • Hopital Louis Pasteur

    Colmar, France

  • Hopital de la Conception - APHM

    Marseille, France

  • Hôpital Privé La Louvière

    Lille, 59042, France

  • Hôpital Saint Louis

    Paris, France

  • Hôpital Tenon

    Paris, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.