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New treatment option for Granulomatosis With Polyangiitis
Official title Safe Effective Therapy With Low-Dose Glucocorticoid in ANCA-Associated Vasculitis (SAFE-LOW)
ClinicalTrials.gov ID: NCT06983821
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for granulomatosis with polyangiitis.
Also referred to as Cytoxan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- New diagnosis of, or relapse of, granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), consistent with Chapel-Hill consensus...
- 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 \ 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...
You likely can't join if
- (any of the following)
- A diagnosis of vasculitis other than GPA or MPA (including eosinophilic granulomatosis with polyangiitis, IgA vasculitis, cryoglobulinemic...
- 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
See the full 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 both of the following:
- eGFR \ 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...
- (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
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.