Status:
COMPLETED
Peptide GAM Immunoadsorption Therapy in Autoimmune Membranous Nephropathy
Lead Sponsor:
Manchester University NHS Foundation Trust
Collaborating Sponsors:
Fresenius AG
Conditions:
Autoimmune Membranous Nephropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- Biopsy confirmed Primary Membranous Nephropathy within the last 3 years
- Active disease despite 6 months of supportive care including ACEi or ARB (Active disease defined as uPCR \> 300mg/mmol or 24 hour urinary protein \>3.5g/1.73m2)
- Disease severity that in the physicians view warrants treatment prior to completion of 6 months supportive care
- Anti-PLA2R titre \> 170 u/ml
- Haemophilus and Pneumococcal vaccinations up to date
- Above the age of 18
- Able to provide informed consent
Exclusion
- Evidence of causes of secondary membranous nephropathy
- eGFR \< 20ml/min
- Treatment with steroids or immunosuppression (including but not limited to cyclophosphamide, MMF or azathioprine) and Biologics (including but limited to Rituximab or belimumab) within 6 months of screening
- Therapeutic Plasma Exchange within 28 days of screening
- Previous renal transplantation
- Co-morbidity, which in physicians' view, would preclude patient from treatment with immunoadsorption.
- Pregnant at time of screening
Key Trial Info
Start Date :
November 30 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03255447
Start Date
November 30 2016
End Date
April 3 2019
Last Update
June 8 2021
Active Locations (3)
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1
Central Manchester University Hospital Foundation Trust
Manchester, Greater Manchester, United Kingdom, M13 9WL
2
Royal Preston Hospital
Preston, Lancashire, United Kingdom, PR2 9HT
3
Salford Royal Infirmary
Salford, Lancashire, United Kingdom, M6 8HD