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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41748
Enrollment
8
Registered
2015-09-09
Start date
2017-05-11
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-GBM disease

Interventions

Participating patients will be treated with daily immunoadsorption, instead of plasma exchange, until anti-GBM titres are undetectable. All other aspects of the treatment (e.g. immunosuppressive tre
Glomerulonephritis
Renal failure

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. Tolerability and adverse events of immunoadsorption. 2. Logistic feasibility. We will specifically assess the time between diagnosis and start of the first immunoadsorption treatment. 3. Costs: both personnel requirements and material costs.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)