Low-Dose Glucocorticoid Therapy for ANCA Vasculitis

(SAFE-LOW Trial)

Recruiting at 1 trial location

Overseen By David Massicotte-Azarniouch, MD, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Hospital Research Institute

Must not be taking: CYC, Prednisone, RTX

Disqualifiers: Other vasculitis, Lupus, Sjögren's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

36 Participants Needed

Trial Summary

What is the purpose of 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.

Research Team

David Massicotte-Azarniouch, MD, MSc

Principal Investigator

The Ottawa Hospital

Eligibility Criteria

This trial is for individuals with ANCA-associated vasculitis, including conditions like Microscopic Polyangiitis and Granulomatosis with Polyangiitis. Participants should have severe kidney involvement. The study will assess if they can safely receive a lower dose of glucocorticoids alongside usual treatments.

Inclusion Criteria

I tested positive for specific autoimmune markers.

My kidney biopsy shows specific types of damage or my urine test shows signs of kidney disease.

My kidney function is severely impaired due to active AAV, with an eGFR less than 40.

Exclusion Criteria

I have been diagnosed with lupus or Sjögren's syndrome.

Pregnant at time of screening

I have a chronic viral infection (HIV, HBV, or HCV).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 doses of IV Cyclophosphamide, Rituximab, and 4 weeks of Prednisone

4 weeks

Pilot Follow-up

Participants are monitored for adherence to the intervention regimen

12 weeks

Full-scale Follow-up

Participants are monitored for serious infections and remission status

26 weeks

Extended Follow-up

Participants are monitored for long-term outcomes such as end-stage kidney disease and glucocorticoid exposure

52 weeks

Treatment Details

Interventions

• Prednisone

Trial Overview The SAFE-LOW trial is testing the safety and effectiveness of a low-dose glucocorticoid therapy given for 4 weeks in combination with standard induction agents (Rituximab or Cyclophosphamide) compared to the current higher-dose standard care in patients with severe kidney disease from vasculitis.

Participant Groups

Group I: Intervention Arm Experimental Treatment 3 Interventions

IV Cyclophosphamide x 2 doses AND Rituximab AND Prednisone x 4 weeks

Group II: Standard of care Active Control 1 Intervention

Participants in this arm receive standard of care treatment induction agent and glucocorticoid dose/duration, left to the discretion of the investigator

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+