Clinical trial NCT02062684: BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: IgA Nephropathy
Keywords: IgAN
IgA Nephropathy
A-623
Blisibimod
Kidney Disease
Persistent proteinuria
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-02-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects achieving reduction in proteinuria from baseline
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in serum immunoglobulins IgA, IgG and IgM
timeFrame: 24 weeks
measure: Percent reduction from baseline in plasma cells and B-cell subsets
timeFrame: 24 weeks
measure: Percent change from baseline in complement C3 and C4
timeFrame: 24 weeks
measure: Proportion of subjects progressing to End Stage Renal Disease
timeFrame: Approximately 104 weeks
measure: Proportion of subjects achieving reduction in proteinuria from baseline
timeFrame: Approximately 104 weeks
measure: Numbers of subjects requiring the addition of corticosteroid or other therapy
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: Investigator Site 852
city: Prague
country: Czechia
facility: Investigator 851
city: Dusseldorf
country: Germany
facility: Investigator Site 905
city: Hong Kong
country: Hong Kong
facility: Investigator Site 101
city: Busan
country: Korea, Republic of
facility: Investigator Site 305
city: Busan
country: Korea, Republic of
facility: Investigator Site 306
city: Daejeon
country: Korea, Republic of
facility: Investigator Site 303
city: Seoul
country: Korea, Republic of
facility: Investigator Site 301
city: Seoul
country: Korea, Republic of
facility: Investigator Site 302
city: Kajang
country: Malaysia
facility: Investigator Site 603
city: Quezon City
country: Philippines
facility: Investigator Site 402
city: Quezon City
country: Philippines
facility: Investigator Site 401
city: Singapore
country: Singapore
facility: Investigator Site 202
city: Singapore
country: Singapore
facility: Investigator Site 201
city: Changhua
country: Taiwan
facility: Investigator Site 704
city: Tainan
country: Taiwan
facility: Investigator Site 705
city: Bangkok
country: Thailand
facility: Investigator Site 504
city: Bangkok
country: Thailand
facility: Investigator Site 505
city: Bangkok
country: Thailand
facility: Investigator Site 503
city: Chang Mai
country: Thailand
facility: Investigator Site 501
city: Bradford
country: United Kingdom
facility: Investigator Site 806
city: Leicester
country: United Kingdom
facility: Investigator Site 801
city: London
country: United Kingdom
facility: Investigator Site 803
Study officials:
References:
citation: 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.