Trial record 3 of 56 for:    "Membranous nephropathy"

Peptide GAM Immunoadsorption Therapy in Autoimmune Membranous Nephropathy (PRISM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03255447
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : August 21, 2017
Fresenius AG
Information provided by (Responsible Party):
Sandip Mitra, Manchester University NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Autoimmune Membranous Nephropathy Device: Immunoadsorption Phase 2

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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial Investigating the Safety and Feasibility of Peptide GAM Immunoadsorption in Anti-PLA2R Positive Autoimmune Membranous Nephropathy
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Immunoadsorption therapy
Peptide GAM immunoadsorption therapy
Device: Immunoadsorption
Fresenius Globaffin

Primary Outcome Measures :
  1. Serum anti-PLA2R titres [ Time Frame: 14 days ]
    Reduction in serum anti-PLA2R titres to normal range

Secondary Outcome Measures :
  1. The incidence of treatment related adverse events as defined by CTCAE v4.0 [ Time Frame: Day 14, 28, 56, 84, 168 and 365 ]
    To assess the safety and tolerability of Immunoadosorption therapy

  2. To determine the effect on disease activity (efficacy) [ Time Frame: Day 14, 28, 56, 84, 168 and 365 ]
    Assessment of reduction in proteinuria level and change in eGFR from baseline

  3. Serum anti-PLA2R titres [ Time Frame: Day 14, 28, 56, 84, 168 and 365 ]
    Kinetic modelling of serum anti-PLA2R levels

  4. Quality of Life [ Time Frame: Day 14, 28, 56, 84, 168 and 365 ]
    To determine the effect on Quality of life measures (EQ5D)

  5. Cost-effectiveness [ Time Frame: Day 14, 28, 56, 84, 168 and 365 ]
    Cost-effectiveness of treatment (Incremental cost-effectiveness ratio)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03255447

Contact: Sandip Mitra
Contact: Patrick Hamilton

United Kingdom
Central Manchester University Hospital Foundation Trust Recruiting
Manchester, Greater Manchester, United Kingdom, M13 9WL
Contact: Sandip Mitra   
Contact: Patrick Hamilton   
Royal Preston Hospital Recruiting
Preston, Lancashire, United Kingdom, PR2 9HT
Contact: Ajay Dhaygude         
Salford Royal Infirmary Recruiting
Salford, Lancashire, United Kingdom, M6 8HD
Contact: Smeeta Sinha         
Sponsors and Collaborators
Manchester University NHS Foundation Trust
Fresenius AG
Principal Investigator: Sandip Mitra Central Manchester University Hospital Foundation Trust

Responsible Party: Sandip Mitra, Consultant Nephrologist (Manchester Royal Infirmary) and Honorary Lecturer, University of Manchester, Manchester University NHS Foundation Trust Identifier: NCT03255447     History of Changes
Other Study ID Numbers: R04240
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sandip Mitra, Manchester University NHS Foundation Trust:
Idiopathic Membranous Nephropathy
Primary Membranous Nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Autoimmune Diseases
Immune System Diseases