CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 704 enrolled
Drug / intervention
Glucocorticoids [Standard Dose] +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00987389
NCT00987389Phase 3Completed
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Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial

University of Pennsylvania·interventional·Posted Sep 30, 2009·Updated May 26, 2020

In Brief

A Phase 3 clinical trial evaluating Plasma Exchange, No Plasma Exchange, and 2 other interventions for Granulomatosis With Polyangiitis (Wegener's) (GPA) and Microscopic Polyangiitis (MPA). Completed, enrolled 704 participants across 98 sites in 15 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGranulomatosis With Polyangiitis (Wegener's) (GPA), Microscopic Polyangiitis (MPA)
CountriesAustralia, Belgium, Canada, Czechia, Denmark, France, Greece, Italy, Japan, Mexico, New Zealand, Norway, Sweden, United Kingdom, United States
CollaboratorsCambridge University Hospitals NHS Foundation Trust, University of Birmingham, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 30, 2009
Enrollment StartMay 1, 2010
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 16.8 years ago

Interventions

Plasma Exchangeprocedure

Plasma exchange is a procedure whereby blood is taken from the body and separated by a machine into blood cells and plasma, which is the liquid part of blood. The plasma is discarded and the blood cells are returned to the body with a plasma substitute.

No Plasma Exchangeother

No plasma exchange.

Glucocorticoids [Standard Dose]drug

During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a standard regimen.

Glucocorticoids [Reduced Dose]drug

During the study, a standard glucocorticoids dose regimen will be compared to a reduced glucocorticoids dose regimen. All subjects' patients will receive the same glucocorticoids dose for the first two weeks then the dose will decrease following a reduced regimen.