Immunoadsorption in Anti-GBM Glomerulonephritis.

NCT02765789 | Completed

• 1 other identifier: 201500361
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Anti-glomerular basement membrane (GBM) glomerulonephritis is a rare autoimmune disease mediated by anti-GBM antibodies and characterized by acute renal failure due to diffuse crescentic glomerulonephritis. Established treatment is cyclophosphamide and corticosteroids to suppress anti-GBM production and daily plasma exchange to remove circulating anti-GBM antibodies. The vast majority of patients with anti-GBM glomerulonephritis develop irreversible end-stage renal failure despite this treatment. Immunoadsorption may lower anti-GBM titres more effectively than plasma exchange. The goal of this interventional open, non-randomized pilot study is to study the efficacy, adverse events, logistic feasibility and costs of immuno-adsorption for the removal of anti-GBM antibodies in patients with acute renal failure due to anti-GBM glomerulonephritis. Eight patients with acute renal failure due to anti-GBM glomerulonephritis with or without accompanying pulmonary involvement will be treated with daily immunoadsorption, instead of plasma exchange, until anti-GBM titres are undetectable. All other aspects of the treatment (e.g. immunosuppressive treatment, renal replacement therapy) will be standard. The primary study parameter is the number of days that anti-GBM antibody titre is above a toxic level, defined as \>30 ELISA units. Secondary study parameters are the tolerability and adverse events of immunoadsorption, the logistic feasibility defined as the time interval between diagnosis and start of first immunoadsorption treatment and costs of immunoadsorption.

Conditions

Anti-glomerular Basement Membrane Glomerulonephritis

Outcome Measures

Primary Outcomes (1)

• Number of days that anti-GBM antibody titre is above a toxic level, defined as >30 ELISA units.

  Nr of Days that anti-GBM title is \>30 units

  60 days after study start

Secondary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  60 days after study start

• Logistic feasibility defined as the time interval between diagnosis and start of first immunoadsorption treatment.

  60 days

• Costs of immunoadsorption (personnel and materials).

  60 days

Study Arms (1)

Immunoadsorption

EXPERIMENTAL

Immunoadsoprtion (Immunosorba). All (anticipated) 8 participants will be treated with immunoadsorption

Device: Immunoadsorption (Immunosorba)

Interventions

Immunoadsorption (Immunosorba) DEVICE

Immunoadsorption as an alternative to plasma exchange

Immunoadsorption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute renal failure due to anti-GBM glomerulonephritis with or without pulmonary involvement. Eligible patients must have a clinical picture met rapidly progressive glomerulonephritis in combination with one of the following:
• Serological evidence of circulating anti-GMB antibodies (Dotblot, Phadia, ELISA). Patients with dual autoantibody positivity (anti-GBM antibodies and ANCA) can participate in this study. 2. Renal biopsy with necrotising glomerulonephritis with linear fluorescence for IgG along the GBM.

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Fresenius Medical Care North America: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Gromiongen, 9713 GZ, Netherlands

Location

Study Officials

• Casper FM Franssen, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 9, 2016
• Study Start: June 1, 2016
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2021
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)