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

September 14, 2017 updated by: Anthera Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia
        • Investigator Site 852
      • Prague, Czechia
        • Investigator 851
  • Germany
      • Dusseldorf, Germany, 40210
        • Investigator Site 905
  • Hong Kong
      • Hong Kong, Hong Kong
        • Investigator Site 101
  • Korea, Republic of
      • Busan, Korea, Republic of, 612-896
        • Investigator Site 305
      • Busan, Korea, Republic of, 614-735
        • Investigator Site 306
      • Daejeon, Korea, Republic of, 301-721
        • Investigator Site 303
      • Seoul, Korea, Republic of, 110-744
        • Investigator site 301
      • Seoul, Korea, Republic of, 137-701
        • Investigator Site 302
  • Malaysia
      • Kajang, Malaysia, 43000
        • Investigator Site 603
  • Philippines
      • Quezon City, Philippines, 1101
        • Investigator Site 402
      • Quezon City, Philippines
        • Investigator Site 401
  • Singapore
      • Singapore, Singapore, 169608
        • Investigator site 202
      • Singapore, Singapore, 308433
        • Investigator site 201
  • Taiwan
      • Changhua, Taiwan, 500
        • Investigator Site 704
      • Tainan, Taiwan, 70428
        • Investigator Site 705
  • Thailand
      • Bangkok, Thailand, 10330
        • Investigator Site 504
      • Bangkok, Thailand, 10400
        • Investigator Site 505
      • Bangkok, Thailand, 10700
        • Investigator Site 503
      • Chang Mai, Thailand, 50200
        • Investigator Site 501
  • United Kingdom
      • Bradford, United Kingdom
        • Investigator Site 806
      • Leicester, United Kingdom
        • Investigator Site 801
      • London, United Kingdom
        • Investigator Site 803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered subcutaneously
Drug: Placebo
Experimental: Blisibimod
Blisibimod administered subcutaneously
Drug: Blisibimod

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects achieving reduction in proteinuria from baseline
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in serum immunoglobulins IgA, IgG and IgM
Time Frame: 24 weeks
24 weeks
Percent reduction from baseline in plasma cells and B-cell subsets
Time Frame: 24 weeks
24 weeks
Percent change from baseline in complement C3 and C4
Time Frame: 24 weeks
24 weeks
Proportion of subjects progressing to End Stage Renal Disease
Time Frame: Approximately 104 weeks
Approximately 104 weeks
Proportion of subjects achieving reduction in proteinuria from baseline
Time Frame: Approximately 104 weeks
Approximately 104 weeks
Numbers of subjects requiring the addition of corticosteroid or other therapy
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Actual)

September 18, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-IGN3321

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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