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

Recruiting Phase 3 Interventional Study
Granulomatosis With Polyangiitis Microscopic Polyangiitis (MPA)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
36 (estimated)
Sponsor
Ottawa Hospital Research Institute · Other
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About This Trial
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 wil…
Trial Locations
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Eligibility Criteria
* 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…
Contacts

David Massicotte-Azarniouch, MD, MSc

613-738-8400

damassicotte@toh.ca

CONTACT