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Could a 4-Week steroid course be safer for vasculitis patients?

NCT ID NCT06983821

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 3 trial is testing whether a 4-week low-dose steroid regimen, given alongside standard drugs like rituximab or cyclophosphamide, is safer and as effective as the usual longer steroid treatment for ANCA vasculitis with severe kidney problems. The study will enroll 36 people with newly diagnosed or relapsed disease. The goal is to reduce serious infections while still controlling the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prednisone (a steroid) given with standard drugs like rituximab or cyclophosphamide
What this could lead to
If successful, this could lead to a safer, shorter steroid treatment for ANCA vasculitis, reducing serious infections while still controlling the disease.
What could go wrong
This is a small pilot phase (36 participants) testing feasibility, so results may not apply broadly. The low steroid dose might not control the disease as well as standard care, risking relapse.

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 36 people

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

Started

Nov 2025

Expected to finish

Feb 2029

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 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.

* New diagnosis of, or relapse of, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill consensus definitions * Positive ELISA test for anti-meyloperoxidase (MPO) or anti-proteinase 3 (PR3) * Severe kidney involvement from active AAV, characterised by both of the following: * eGFR \< 40ml/min/1.73m2 (Patients known to have a stable eGFR \<40 ml/min/1.73m2 for \>3 months prior to enrollment are NOT eligible) * Biopsy proven at least focal necrotizing/crescentic glomerulonephritis OR active urinary sediment by microscopy (greater than or equal to 10 red blood cells \[RBC\]/high power field with erythrocyte casts or greater than or equal to 20% dysmorphic RBCs or greater than or equal to 5% acanthocytes without an alternative cause. Exclusion Criteria (any of the following) * A diagnosis of vasculitis other than GPA or MPA (including eosinophilic granulomatosis with polyangiitis, IgA vasculitis, cryoglobulinemic vasculitis, rheumatoid vasculitis) * Positive anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition * A diagnosis of systemic lupus erythematosus or Sjögren's syndrome * Receipt of dialysis for \>21 days immediately prior to randomization or prior renal transplant * Age \<18 * Pregnant at time of screening * Treatment with \>1 IV dose of CYC and/or \>14 days PO CYC and/or \>14 days of prednisone/prednisone (less than or equal to 30mg/day) and/or \>1 dose of RTX within the 28 days immediately prior to randomization * Chronic viral infection: HIV. HBV or HCV * Untreated latent mycobacterium tuberculosis infection * Active infection at time of presentation * A comorbidity or condition that, in the opinion of the investigator, precludes the use of GC, CYC or RTX

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • St-Joseph's Hospital

    NOT_YET_RECRUITING

    Hamilton, Ontario, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, Canada

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