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

NCT ID: NCT02062684

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Blisibimod

Blisibimod administered subcutaneously

Group Type EXPERIMENTAL

Blisibimod

Intervention Type DRUG

Placebo

Placebo administered subcutaneously

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Blisibimod

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anthera Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigator Site 852

Olomouc, , Czechia

Site Status

Investigator 851

Prague, , Czechia

Site Status

Investigator Site 905

Düsseldorf, , Germany

Site Status

Investigator Site 101

Hong Kong, , Hong Kong

Site Status

Investigator Site 603

Kajang, , Malaysia

Site Status

Investigator Site 402

Quezon City, , Philippines

Site Status

Investigator Site 401

Quezon City, , Philippines

Site Status

Investigator Site 202

Singapore, , Singapore

Site Status

Investigator Site 201

Singapore, , Singapore

Site Status

Investigator Site 305

Busan, , South Korea

Site Status

Investigator Site 306

Busan, , South Korea

Site Status

Investigator Site 303

Daejeon, , South Korea

Site Status

Investigator Site 301

Seoul, , South Korea

Site Status

Investigator Site 302

Seoul, , South Korea

Site Status

Investigator Site 704

Changhua, , Taiwan

Site Status

Investigator Site 705

Tainan City, , Taiwan

Site Status

Investigator Site 504

Bangkok, , Thailand

Site Status

Investigator Site 505

Bangkok, , Thailand

Site Status

Investigator Site 503

Bangkok, , Thailand

Site Status

Investigator Site 501

Chang Mai, , Thailand

Site Status

Investigator Site 806

Bradford, , United Kingdom

Site Status

Investigator Site 801

Leicester, , United Kingdom

Site Status

Investigator Site 803

London, , United Kingdom

Site Status

Countries

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Czechia Germany Hong Kong Malaysia Philippines Singapore South Korea Taiwan Thailand United Kingdom

References

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Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.

Reference Type DERIVED
PMID: 26032537 (View on PubMed)

Other Identifiers

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AN-IGN3321

Identifier Type: -

Identifier Source: org_study_id