BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02052219
• Other study ID #: AN-IGN3331
• Status: Withdrawn
• Phase: Phase 3
• First received: January 29, 2014
• Last updated: July 28, 2015
• Start date: October 2014
• Est. completion date: October 2021

Study information

• Verified date: July 2015
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effect of blisibimod plus standard of care versus placebo plus standard of care alone on the proportion of subjects achieving improvement in renal disease parameters.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2021
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older.

• Biopsy-proven IgA nephropathy

• Proteinuria = 2g/24hr or equivalent

• Receiving physician-directed optimized standard of care that includes ACEI and/or ARB.

• Estimated glomerular filtration rate (eGFR) >40mL/min/1.73m2

Exclusion Criteria:

• Clinical or histologic evidence of non-IgA-related glomerulonephritis

• IgA nephropathy with greater than 50% glomerulosclerosis or cortical scarring

• Meets eGFR criteria

• 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Blisibimod
Blisibimod administered subcutaneously
• Placebo
Placebo administered subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects to achieve the proteinuria threshold		Week 24	No
Primary	The proportion of subjects who progress to end-stage renal disease		approximately 5 years	No
Secondary	Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets		Week 24	No
Secondary	Number of Participants with Adverse Events		Week 24	Yes
Secondary	Change from baseline in serum creatinine		Week 24	No
Secondary	Change from baseline in eGFR		Week 24	No
Secondary	The proportion of subjects requiring the addition of corticosteroid or other therapy		Week 24	No