An interventional study of Immunoadsorption in Autoimmune Membranous Nephropathy, sponsored by Manchester University NHS Foundation Trust. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by Manchester University NHS Foundation Trust · Not applicable, Interventional, and Treatment
Autoimmune Membranous Nephropathy is now understood to be a condition caused by the immune system although the exact mechanism is not completely known. This study aims to remove the offending part of the immune system using immunoadsorption to not only treat the disease but also use the opportunity to better understand the mechanism of disease. This will allow more targeted treatment in the future with less complications and side effects.
Membranous nephropathy (MN) is among the most common causes of nephrotic syndrome in adults worldwide. The majority of patients will remain stable with either complete remission or partial remission but approximately 20% will progress slowly to end stage renal disease necessitating the need for renal replacement therapy (RRT).
Current standard therapy for primary (or autoimmune) membranous nephropathy is a regime of rotating high dose steroids and immunosuppression was first described in the mid-nineties and has been the mainstay of treatment since but comes with a high side effect burden.
Idiopathic membranous nephropathy is now understood to be an autoimmune disease characterised by the presence of IgG autoantibodies to M-Type Phospholipase A2 Receptor (anti-PLA2R). Immunoadsorption is a method of removing specific circulating immunoglobulins and has been shown to remove over 80% of circulating IgG with a single session immunoadsorption of 2.5 plasma volumes, with albumin and antithrombin III almost unaffected. With multiple sessions this can rise to over 98%.
Immunoadsorption therapy has been in use for a number of years and this study will use Peptide GAM Immunoadsorption therapy developed by Fresenius Healthcare. This uses two systems, the Art Universal and ADAsorb. The Art Universal became commercially available in 2005 and the ADAsorb in 2002.
Exclusion Criteria:
Peptide GAM immunoadsorption therapy
Device: Immunoadsorption
Fresenius Globaffin
Serum anti-PLA2R titres
Reduction in serum anti-PLA2R titres to normal range
Time frame: 14 days
The incidence of treatment related adverse events as defined by CTCAE v4.0
To assess the safety and tolerability of Immunoadosorption therapy
Time frame: Day 14, 28, 56, 84, 168 and 365
To determine the effect on disease activity (efficacy)
Assessment of reduction in proteinuria level and change in eGFR from baseline
Time frame: Day 14, 28, 56, 84, 168 and 365
Serum anti-PLA2R titres
Kinetic modelling of serum anti-PLA2R levels
Time frame: Day 14, 28, 56, 84, 168 and 365
To determine the effect on Quality of life measures (EQ5D)
To determine the effect on Quality of life measures (EQ5D)
Time frame: Day 14, 28, 56, 84, 168 and 365
Cost-effectiveness
Cost-effectiveness of treatment (Incremental cost-effectiveness ratio)
Time frame: Day 14, 28, 56, 84, 168 and 365
Plan to share: No
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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Manchester University NHS Foundation Trust