NCT03255447

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 21, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2019

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2.3 years

First QC Date

August 11, 2017

Last Update Submit

June 7, 2021

Conditions

Autoimmune Membranous Nephropathy

Keywords

Idiopathic Membranous NephropathyPrimary Membranous NephropathyImmunoadsorptionApharesis

Outcome Measures

Primary Outcomes (1)

  • Serum anti-PLA2R titres

    Reduction in serum anti-PLA2R titres to normal range

    14 days

Secondary Outcomes (5)

  • The incidence of treatment related adverse events as defined by CTCAE v4.0

    Day 14, 28, 56, 84, 168 and 365

  • To determine the effect on disease activity (efficacy)

    Day 14, 28, 56, 84, 168 and 365

  • Serum anti-PLA2R titres

    Day 14, 28, 56, 84, 168 and 365

  • To determine the effect on Quality of life measures (EQ5D)

    Day 14, 28, 56, 84, 168 and 365

  • Cost-effectiveness

    Day 14, 28, 56, 84, 168 and 365

Study Arms (1)

Immunoadsorption therapy

EXPERIMENTAL

Peptide GAM immunoadsorption therapy

Device: Immunoadsorption

Interventions

ImmunoadsorptionDEVICE

Fresenius Globaffin

Immunoadsorption therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Central Manchester University Hospital Foundation Trust

Manchester, Greater Manchester, M13 9WL, United Kingdom

Location

Royal Preston Hospital

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Salford Royal Infirmary

Salford, Lancashire, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Component RemovalTherapeuticsSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Sandip Mitra

    Central Manchester University Hospital Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2017

First Posted

August 21, 2017

Study Start

November 30, 2016

Primary Completion

April 3, 2019

Study Completion

April 3, 2019

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)