Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis

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.

Conditions

• Granulomatosis With Polyangiitis (Wegener's) (GPA)
• Microscopic Polyangiitis (MPA)

Interventions

PROCEDURE

Plasma Exchange

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.

OTHER

No Plasma Exchange

No plasma exchange.

DRUG

Glucocorticoids [Standard Dose]

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.

DRUG

Glucocorticoids [Reduced Dose]

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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• University of Birmingham

  collaborator OTHER

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  collaborator NIH

• University of Pennsylvania

  lead OTHER

Principal Investigators

• David Jayne, MD · Cambridge University Hospitals NHS Foundation Trust

• Peter Merkel, MD, MPH · University of Pennsylvania

• Michael Walsh, MD · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2017-08-31

Completion

2017-08-31

Countries

• United States
• Australia
• Belgium
• Canada
• Czechia
• Denmark
• France
• Greece
• Italy
• Japan
• Mexico
• New Zealand
• Norway
• Sweden
• United Kingdom

Study Locations