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

IgA Nephropathy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02062684
• Other study ID #: AN-IGN3321
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 12, 2014
• Last updated: September 14, 2017
• Start date: June 2013
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2017
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 30, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Blisibimod

• Placebo

Locations

Country	Name	City	State
Czechia	Investigator Site 852	Olomouc
Czechia	Investigator 851	Prague
Germany	Investigator Site 905	Dusseldorf
Hong Kong	Investigator Site 101	Hong Kong
Korea, Republic of	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
Malaysia	Investigator Site 603	Kajang
Philippines	Investigator Site 401	Quezon City
Philippines	Investigator Site 402	Quezon City
Singapore	Investigator Site 201	Singapore
Singapore	Investigator Site 202	Singapore
Taiwan	Investigator Site 704	Changhua
Taiwan	Investigator Site 705	Tainan
Thailand	Investigator Site 503	Bangkok
Thailand	Investigator Site 504	Bangkok
Thailand	Investigator Site 505	Bangkok
Thailand	Investigator Site 501	Chang Mai
United Kingdom	Investigator Site 806	Bradford
United Kingdom	Investigator Site 801	Leicester
United Kingdom	Investigator Site 803	London

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Countries where clinical trial is conducted

Czechia,  Germany,  Hong Kong,  Korea, Republic of,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand,  United Kingdom, 

Outcome

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