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

Phase 2

Completed

• Conditions: IgA Nephropathy
• Interventions: Drug: Blisibimod; Drug: Placebo

• Registration Number: NCT02062684
• Lead Sponsor: Anthera Pharmaceuticals

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Primary Completion: 2017-03
• Study Completion: 2017-06-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-14
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blisibimod	Blisibimod	Blisibimod administered subcutaneously
Placebo	Placebo	Placebo administered subcutaneously

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving reduction in proteinuria from baseline	24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (23)

Investigator Site 852; 🇨🇿 Olomouc, Czechia

Investigator 851; 🇨🇿 Prague, Czechia

Investigator Site 905; 🇩🇪 Dusseldorf, Germany

Investigator Site 101; 🇭🇰 Hong Kong, Hong Kong

Investigator Site 305; 🇰🇷 Busan, Korea, Republic of

Investigator Site 306; 🇰🇷 Busan, Korea, Republic of

Investigator Site 303; 🇰🇷 Daejeon, Korea, Republic of

Investigator Site 301; 🇰🇷 Seoul, Korea, Republic of

Investigator Site 302; 🇰🇷 Seoul, Korea, Republic of

Investigator Site 603; 🇲🇾 Kajang, Malaysia

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