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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. The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

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

FieldValue
Enrollment Target 704 participants
Start Date 2010-05
Est. Completion 2017-08
Phase Phase 3

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT00987389

The ClinicalTrials.gov registry entry for NCT00987389 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 704 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.