RecruitingPhase 3NCT06983821

Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)

Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW) Trial


Sponsor

Ottawa Hospital Research Institute

Enrollment

36 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cyclophosphamide, a drug called Prednisone, and others for people with granulomatosis with polyangiitis and microscopic polyangiitis (mpa). The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

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

DRUGStandard of Care (SOC)

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

DRUGPrednisone

4 weeks prednisone taper

DRUGRituximab (R)

Rituximab infusions, dosing and schedule at clinician/investigator discretion


Locations(2)

St-Joseph's Hospital

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT06983821


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