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Completed

NCT Number: NCT02062684

BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administration in addition to standard therapy in patients with biopsy proven IgA Nephropathy with persistent proteinuria of between 1-6 g/day.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Investigator Site 852, Olomouc, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 - 65 years of age, inclusive
  • Biopsy-proven IgA nephropathy
  • Receiving stable, clinically-optimized ACEI and/or ARB
  • Proteinuria ≥ 1g/24hr but ≤ 6g/24hr at 2 consecutive time points

Exclusion criteria

  • Clinical or histologic evidence of non-IgA-related glomerulonephritis
  • IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring
  • Meets eGFR criteria
  • History of treatment with oral or parenteral corticosteroids within 3 months or immunosuppressants within 6 months
  • Malignancy within past 5 years
  • Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
  • Liver disease
  • Neutropenia
  • Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
  • History of active tuberculosis or a history of tuberculosis infection
  • Pregnant or nursing

Treatment and study plan

Blisibimod

Drug

Placebo

Drug

Primary outcomes

  1. Proportion of subjects achieving reduction in proteinuria from baseline

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline in serum immunoglobulins IgA, IgG and IgM

    Time frame: 24 weeks

  2. Percent reduction from baseline in plasma cells and B-cell subsets

    Time frame: 24 weeks

  3. Percent change from baseline in complement C3 and C4

    Time frame: 24 weeks

  4. Proportion of subjects progressing to End Stage Renal Disease

    Time frame: Approximately 104 weeks

  5. Proportion of subjects achieving reduction in proteinuria from baseline

    Time frame: Approximately 104 weeks

  6. Numbers of subjects requiring the addition of corticosteroid or other therapy

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Anthera Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 14, 2014
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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