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

Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW) (NCT06983821) is a Phase 3 interventional studying Granulomatosis With Polyangiitis and Microscopic Polyangiitis (MPA), sponsored by Ottawa Hospital Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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 will begin as a pilot to assess feasibility of recruitment and of adherence to the intervention.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Granulomatosis With Polyangiitis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

* 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

* 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

Treatments Being Tested

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

St-Joseph's Hospital

Hamilton, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06983821), the sponsor (Ottawa Hospital Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06983821 clinical trial studying?

Who can participate in NCT06983821?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06983821?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06983821. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06983821. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.