IgA NephropathyPhase 2/3NCT02062684
BRIGHT-SC: Blisibimod Response in IgA Nephropathy Following At-Home Treatment by Subcutaneous Administration
A Phase 2/3 study testing Blisibimod in people with IgA Nephropathy, run by Anthera Pharmaceuticals at 23 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- 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
- 57 participants
- Where
- 23 sitesin 10 countries
- Study dates
- Jun 2013to 30 Jun 2017
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
23 sites in 10 countries.
23 sites in 10 countries
South Korea5 sites
Investigator Site 305
Busan, 612-896
Investigator Site 306
Busan, 614-735
Investigator Site 303
Daejeon, 301-721
Investigator Site 301
Seoul, 110-744
Investigator Site 302
Seoul, 137-701
Thailand4 sites
Investigator Site 504
Bangkok, 10330
Investigator Site 505
Bangkok, 10400
Investigator Site 503
Bangkok, 10700
Investigator Site 501
Chang Mai, 50200
United Kingdom3 sites
Investigator Site 806
Bradford
Investigator Site 801
Leicester
Investigator Site 803
London
Philippines2 sites
Investigator Site 402
Quezon City, 1101
Investigator Site 401
Quezon City
Singapore2 sites
Investigator Site 202
Singapore, 169608
Investigator Site 201
Singapore, 308433
Taiwan2 sites
Investigator Site 704
Changhua, 500
Investigator Site 705
Tainan, 70428
About this study
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
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.
- Conditions
- IgA Nephropathy
- Being tested
- Blisibimod, Placebo
- Keywords
- IgAN, IgA Nephropathy, A-623, Blisibimod, Kidney Disease, Persistent proteinuria
- Medical subject headings
- Glomerulonephritis, IGA, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlisibimodDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Blisibimod | Experimental | Blisibimod administered subcutaneously Receives: Drug: Blisibimod |
| Placebo | Placebo comparator | Placebo administered subcutaneously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving reduction in proteinuria from baseline
Measured: 24 weeks
Secondary outcomes (6)
Change from baseline in serum immunoglobulins IgA, IgG and IgM
Measured: 24 weeks
Percent reduction from baseline in plasma cells and B-cell subsets
Measured: 24 weeks
Percent change from baseline in complement C3 and C4
Measured: 24 weeks
Proportion of subjects progressing to End Stage Renal Disease
Measured: Approximately 104 weeks
Proportion of subjects achieving reduction in proteinuria from baseline
Measured: Approximately 104 weeks
Numbers of subjects requiring the addition of corticosteroid or other therapy
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 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
- NCT02062684
- Sponsor's protocol ID
- AN-IGN3321
- Status last verified
- Sep 2017
- First submitted
- 12 Feb 2014
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26032537
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02062684
- Acronym / sponsor ID
- AN-IGN3321
- Conditions
- IgA Nephropathy
- Keywords
- IgAN, IgA Nephropathy, A-623, Blisibimod, Kidney Disease, Persistent proteinuria
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 14 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 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.
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: BlisibimodBlisibimod administered subcutaneously |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Blisibimod | Drug | Blisibimod |
| Placebo | Drug | Placebo |
Primary outcome
Proportion of subjects achieving reduction in proteinuria from baseline
Time frame: 24 weeks
6 secondary outcomes
Change from baseline in serum immunoglobulins IgA, IgG and IgM
Time frame: 24 weeks
Percent reduction from baseline in plasma cells and B-cell subsets
Time frame: 24 weeks
Percent change from baseline in complement C3 and C4
Time frame: 24 weeks
Proportion of subjects progressing to End Stage Renal Disease
Time frame: Approximately 104 weeks
Proportion of subjects achieving reduction in proteinuria from baseline
Time frame: Approximately 104 weeks
Numbers of subjects requiring the addition of corticosteroid or other therapy
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 26032537Yeo SC, Liew A, Barratt J. Emerging therapies in immunoglobulin A nephropathy. Nephrology (Carlton). 2015 Nov;20(11):788-800. doi: 10.1111/nep.12527.
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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.
23 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Blisibimod in people with IgA Nephropathy, run by Anthera Pharmaceuticals at 23 sites in 10 countries.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in South Korea, Thailand, United Kingdom, Czechia, Philippines and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects achieving reduction in proteinuria from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02062684, which also lists 1 linked publication.
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 18 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.