IgA NephropathyPhase 3NCT02052219
BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy
A Phase 3 study testing Blisibimod in people with IgA Nephropathy, run by Anthera Pharmaceuticals.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Blisibimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
About this study
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
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.
- Conditions
- IgA Nephropathy
- Being tested
- Blisibimod, Placebo
- Keywords
- Blisibimod, IgA nephropathy, BAFF, BLyS
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlisibimodDrug
Blisibimod administered subcutaneously
PlaceboDrug
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Blisibimod | Experimental | Not described Receives: Drug: Blisibimod |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects to achieve the proteinuria threshold
Measured: Week 24
The proportion of subjects who progress to end-stage renal disease
Measured: approximately 5 years
Secondary outcomes (5)
Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets
Measured: Week 24
Number of Participants with Adverse Events
Measured: Week 24
Change from baseline in serum creatinine
Measured: Week 24
Change from baseline in eGFR
Measured: Week 24
The proportion of subjects requiring the addition of corticosteroid or other therapy
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052219
- Sponsor's protocol ID
- AN-IGN3331
- Status last verified
- Jul 2015
- First submitted
- 29 Jan 2014
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02052219
- Acronym / sponsor ID
- AN-IGN3331
- Conditions
- IgA Nephropathy
- Keywords
- Blisibimod, IgA nephropathy, BAFF, BLyS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blisibimod | Experimental | Drug: Blisibimod |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BlisibimodBlisibimod administered subcutaneously | Drug | Blisibimod |
| PlaceboPlacebo administered subcutaneously | Drug | Placebo |
Primary outcome
The proportion of subjects to achieve the proteinuria threshold
Time frame: Week 24
The proportion of subjects who progress to end-stage renal disease
Time frame: approximately 5 years
5 secondary outcomes
Change from baseline in serum immunoglobulins IgA, IgG and IgM, plasma cells and B cell subsets
Time frame: Week 24
Number of Participants with Adverse Events
Time frame: Week 24
Change from baseline in serum creatinine
Time frame: Week 24
Change from baseline in eGFR
Time frame: Week 24
The proportion of subjects requiring the addition of corticosteroid or other therapy
Time frame: Week 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
Related trials for IgA Nephropathy
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blisibimod in people with IgA Nephropathy, run by Anthera Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects to achieve the proteinuria threshold (time frame: Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.