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RECRUITING
NCT06983821
PHASE3

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

Sponsor: Ottawa Hospital Research Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2025-11-10

Completion Date

2029-02

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

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

DRUG

Standard of Care (SOC)

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

DRUG

Prednisone

4 weeks prednisone taper

DRUG

Rituximab (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