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

NCT06983821 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-01-30

No results posted yet for this study

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)

Interventions

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

DRUG

Cyclophosphamide

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

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • David Massicotte-Azarniouch, MD, MSc · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-10
Primary Completion
2028-02-29
Completion
2029-02-28

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06983821 on ClinicalTrials.gov