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| Name | Class |
|---|---|
| Fresenius AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunoadsorption therapy | Experimental | Peptide GAM immunoadsorption therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoadsorption | Device | Fresenius Globaffin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum anti-PLA2R titres | Reduction in serum anti-PLA2R titres to normal range | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of treatment related adverse events as defined by CTCAE v4.0 | To assess the safety and tolerability of Immunoadosorption therapy | Day 14, 28, 56, 84, 168 and 365 |
| To determine the effect on disease activity (efficacy) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandip Mitra | Central Manchester University Hospital Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Manchester University Hospital Foundation Trust | Manchester | Greater Manchester | M13 9WL | United Kingdom | ||
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| ID | Term |
|---|---|
| D015433 | Glomerulonephritis, Membranous |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
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Assessment of reduction in proteinuria level and change in eGFR from baseline
| Day 14, 28, 56, 84, 168 and 365 |
| Serum anti-PLA2R titres | Kinetic modelling of serum anti-PLA2R levels | 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) | Day 14, 28, 56, 84, 168 and 365 |
| Cost-effectiveness | Cost-effectiveness of treatment (Incremental cost-effectiveness ratio) | Day 14, 28, 56, 84, 168 and 365 |
| Royal Preston Hospital |
| Preston |
| Lancashire |
| PR2 9HT |
| United Kingdom |
| Salford Royal Infirmary | Salford | Lancashire | M6 8HD | United Kingdom |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013514 | Surgical Procedures, Operative |