Phase 3
N=704
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
Granulomatosis With Polyangiitis (Wegener's) (GPA) · Microscopic Polyangiitis (MPA)
Bottom Line
View on ClinicalTrials.gov: NCT00987389 ↗Enrolled (actual)
704
Serious AEs
63.8%
Results posted
May 2020
Primary outcome: Primary: Composite of i) All-cause Mortality or ii) End-stage Renal Disease — 100; 109 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Plasma Exchange (Procedure); No Plasma Exchange (Other); Glucocorticoids [Standard Dose] (Drug); Glucocorticoids [Reduced Dose] (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of i) All-cause Mortality or ii) End-stage Renal Disease |
100; 109 | — |
| SECONDARY Number of Participants With Sustained Remission |
200; 197 | — |
| SECONDARY Rate of Serious Infection Events |
145; 132 | — |
| SECONDARY Health-related Quality of Life Using the SF-36 Physical Composite |
39.04; 37.96 | — |
| SECONDARY Health-related Quality of Life Using the SF-36 Mental Composite |
51.94; 51.40 | — |
| SECONDARY Health-related Quality of Life Using the EQ-5D Index Descriptive System |
0.79; 0.77 | — |
Summary
The purpose of this study is to determine whether plasma exchange as well as immunosuppressive therapy are effective in reducing death and end-stage renal disease (ESRD). The trial will also study whether a reduced cumulative dosing regimen of glucocorticoids is as effective as a standard disease regimen.
The FDA-OOPD is one of the funding sources for this study.
Eligibility Criteria
Inclusion Criteria
- New or previous clinical diagnosis of granulomatosis with polyangiitis or microscopic polyangiitis consistent with the Chapel-Hill consensus definitions
AND
- Positive test for proteinase 3-ANCA or myeloperoxidase-ANCA
AND
- Severe vasculitis defined by at least one of the following:
- Renal involvement characterized by both of the following:
- Renal biopsy demonstrating focal necrotizing glomerulonephritis or active urine sediment characterized by glomerular haematuria or red cell casts and proteinuria
AND
- eGFR 1 g/dL)
- Increased diffusing capacity of carbon dioxide
- Provision of informed consent by patient or a surrogate decision maker
Exclusion Criteria
- A diagnosis of vasculitis other than granulomatosis with polyangiitis or microscopic polyangiitis
- Positive serum anti-glomerular basement membrane antibody test or renal biopsy demonstrating linear glomerular immunoglobulin deposition
- Receipt of dialysis for >21 days immediately prior to randomization or prior renal transplant
- Age 1 IV dose of cyclophosphamide and/or >14 days of oral cyclophosphamide and/or >14 days of prednisone/prednisolone (>30 mg/day) and/or >1 dose of rituximab within the 28 days immediately prior to randomization
- A comorbidity that, in the opinion of the investigator, precludes the use of cyclophosphamide, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange
- Plasma exchange in 3 months prior to randomization
Data sourced from ClinicalTrials.gov (NCT00987389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.