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NCT00987389 · ClinicalTrials.gov registry record · Phase 3
Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis
A Phase 3 study of Microscopic Polyangiitis (MPA) and Granulomatosis With Polyangiitis (Wegener's) (GPA), sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 704
- Enrollment target
- 20
- Study locations
NCT00987389: Completed Phase 3 study of Microscopic Polyangiitis (MPA) and Granulomatosis With Polyangiitis (Wegener's) (GPA), sponsored by University of Pennsylvania.
NCT00987389 is a Phase 3 study of Microscopic Polyangiitis (MPA) and Granulomatosis With Polyangiitis (Wegener's) (GPA) that has completed, run by University of Pennsylvania. The registered enrollment target is 704 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00987389, a Phase 3 study of Microscopic Polyangiitis (MPA) and Granulomatosis With Polyangiitis (Wegener's) (GPA), has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 704 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary outcome was a composite of death from any cause or end-stage renal disease (ESRD), defined as ≥12 continuous weeks of renal replacement therapy.
Conditions Studied
Interventions
- PROCEDURE Plasma Exchange
- OTHER No Plasma Exchange
- DRUG Glucocorticoids [Standard Dose]
- DRUG Glucocorticoids [Reduced Dose]
Study Locations (20)
New South Wales
- Concord Repatriation General Hospital - Concord
- John Hunter Hospital, - New Lambton Heights
- Prince of Wales Hospital - Randwick
- Royal North Shore Hospital - St Leonards
Queensland
- Royal Brisbane and Women's Hospital - Herston
- Nambour Hospital - Nambour
- Princess Alexandra Hospital - Woolloongabba
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
South Australia
- Flinders Medical Centre, - Adelaide
- Royal Adelaide Hospital - Adelaide
California
- Cedars-Sinai Medical Center - Los Angeles
Massachusetts
- Boston University School of Medicine - Boston
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 704 participants |
| Start Date | 2010-05 |
| Est. Completion | 2017-08 |
| Phase | Phase 3 |
What the finished NCT00987389 record still lists
NCT00987389 is an interventional study that assigns participants to a tested intervention. The registered 704 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 2 conditions, with Microscopic Polyangiitis (MPA) appearing as the primary indexed condition, and to 4 interventions - of which Plasma Exchange is the first listed.
NCT00987389 names 20 study sites across 13 states, led by New South Wales, Queensland, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00987389 about?
NCT00987389 is a clinical study titled "Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis". 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 re...
What is the current status of trial NCT00987389?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 704 participants. The study started on 2010-05. Estimated completion is 2017-08.
What conditions does trial NCT00987389 study?
This clinical trial studies the following conditions: Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (Wegener's) (GPA).
What interventions are being tested in trial NCT00987389?
The interventions under investigation include: Plasma Exchange (PROCEDURE), No Plasma Exchange (OTHER), Glucocorticoids [Standard Dose] (DRUG), Glucocorticoids [Reduced Dose] (DRUG).
Who is sponsoring clinical trial NCT00987389?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00987389 being conducted?
This trial has 20 study locations across California, Massachusetts, Minnesota, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Microscopic Polyangiitis (MPA)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00987389's enrollment target sits among peer trials
704 506th of 2000 higher than 1,495 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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