Immunoadsorption in anti-glomerular basement membrane glomerulonephritis, a pilot study.

Completed

Conditions: Anti-GBM disease
in combination with pulmonary involvement: Goodpasture's disease.
10003816
10029149

Registration Number: NL-OMON41748

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

Acute renal failure due to anti-GBM glomerulonephritis with or without accompanying pulmonary involvement. Eligible patients must have a clinical picture met rapidly progressive glomerulonephritis in combination with one of the following: 1. serological evidence of circulating anti-GMB antibodies (Dotblot, Phadia, ELISA); 2. Renal biopsy with necrotising glomerulonephritis with linear fluorescence for IgG along the GBM. Notably, in case of serological evidence of circulating anti-GBM antibodies, a renal biopsy is not mandatory for inclusion in this study.

Exclusion Criteria

There are no exclusion criteria. Because of the severity of the disease also patients with a short life expectancy will be included.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Plasma levels of anti-GBM before and after each immunoadsorption treatment. The<br /><br>main study parameter is the number of days that anti-GBM antibody titre is<br /><br>above a toxic level, defined as >30 ELISA units. Courses of anti-GBM titres<br /><br>will be compared with an historical cohort of patients with anti-GBM disease<br /><br>treated with plasma exchange. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Tolerability and adverse events of immunoadsorption.<br /><br>2. Logistic feasibility. We will specifically assess the time between diagnosis<br /><br>and start of the first immunoadsorption treatment.<br /><br>3. Costs: both personnel requirements and material costs. </p><br>