Recruiting
Phase 3

Glucocorticoids with Induction Agents

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06983821

Conditions

Granulomatosis With Polyangiitis

Microscopic Polyangiitis (MPA)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cyclophosphamide

Standard of Care (SOC)

Prednisone

Rituximab (R)

Study Details

Brief summary:

The purpose of this study is to determine the safety and efficacy of a therapeutic regimen consisting of 4 weeks of glucocorticoids given with a combination of the usual induction agents for ANCA-associated vasculitis. The trial will compare this regimen to the current standard of care treatment and glucocorticoid dosing for ANCA-associated vasculitis with severe kidney involvement. This trial will begin as a pilot to assess feasibility of recruitment and of adherence to the intervention.

Conditions

Granulomatosis With Polyangiitis

Microscopic Polyangiitis (MPA)

Study ID

NCT06983821

Start date

Nov 10, 2025

Status verified date

Jan, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

IV Cyclophosphamide x 2 doses AND Rituximab AND Prednisone x 4 weeks

active comparator: Standard of care

Participants in this arm receive standard of care treatment induction agent and glucocorticoid dose/duration, left to the discretion of the investigator

Interventions

Cyclophosphamide

IV Cyclophosphamide 15mg/kg/dose (age and eGFR adjusted), 2 doses 2 weeks apart

Standard of Care (SOC)

Participants will receive standard of care induction agent and glucocorticoid taper, at investigator discretion

Prednisone

4 weeks prednisone taper

Rituximab (R)

Rituximab infusions, dosing and schedule at clinician/investigator discretion

Primary outcome measure

  • Pilot trial: percent adherence to intervention regimen [ Time Frame: 12 weeks ]
  • Full-scale trial: Rate of serious infection [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

David Massicotte-Azarniouch, MD, MSc

613-738-8400damassicotte@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • ANCA-associated vasculitis
  • cyclophosphamide
  • glucoccorticoid
  • rituximab
  • vasculitis
  • granulomatosis with polyangiitis
  • microscopic polyangiitis
  • GPA
  • MPA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-01-30.