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
Among 12 studies in Glomerulonephritis, Membranous with a site in United Kingdom — 4 open to participants now, 5 under way, 2 of them phase 3. Glomerulonephritis, Membranous · United Kingdom.
Among the 12 studies in Glomerulonephritis, Membranous with a site in United Kingdom, this one is the 9th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2016, is the only one with no phase, and was the 4th registered.
146 studies on the registry are indexed under Glomerulonephritis, Membranous; 60 are open to participants now.
Browse Glomerulonephritis, Membranous studies →4 of the 12 studies in Glomerulonephritis, Membranous with a site in United Kingdom are open now. Recruiting first, the newest first:
AstraZeneca · Sites in United Kingdom, United States, Belgium and 6 more countries
Ages 18–75
Vertex Pharmaceuticals Incorporated · Sites in United Kingdom, United States, Australia and 11 more countries
Ages 18–75
Alexion Pharmaceuticals, Inc. · Sites in United Kingdom, United States, Argentina and 7 more countries
Ages 18–75
UK Kidney Association · Sites in United Kingdom
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 41 Glomerulonephritis, Membranous studies recruiting now, 14 (34%) set no upper age limit and 14 (34%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 9 · Phase 3 2 · Phase 4 1
First in 2009; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 12 is below the median of 46 across 105 interventional studies indexed under Glomerulonephritis, Membranous.
Median enrollment 30 across the 11 interventional studies, 35,000 across the 1 observational. Of the 6 that completed or were terminated, 4 (67%) have results posted.
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9 of 12 have an industry lead sponsor. The 10 most frequent:
Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.
Manchester University NHS Foundation Trust has 1 study filed under Glomerulonephritis, Membranous — fewer than ten, so there is no comparison to draw.
2 of the studies in Glomerulonephritis, Membranous with a site in United Kingdom that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05707377Phase 3BeOne MedicinesA Study to Examine the Efficacy and Safety of Zanubrutinib Given to Adults With Primary Membranous Nephropathy | 2027-10 |
| NCT07157787Alexion Pharmaceuticals, Inc.Study of ALXN1920 in Adult Participants With Primary Membranous Nephropathy (PMN) | 2027-07-02 |
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Among the 12 studies in Glomerulonephritis, Membranous with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Ran from Nov 2016 to primary completion in Apr 2019, 28 months.
How these figures are worked out, and which studies are left out of them.
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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Glomerulonephritis, Membranous →
Manchester University NHS Foundation Trust →