Primary IgA Nephropathy| IONIS-FB-LRx
A Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Participants With Primary IgA Nephropathy
This is a Phase 2, single arm open-label clinical study in up to 10 participants that will consist of screening period (which may include a titration of maximum dose/maximally tolerated dose of angiotensin converting enzyme (ACE) and/or angiotensin II receptor blocker (ARB)), a 24-week treatment period and a 12-week post-treatment follow-up evaluation period.
IONIS-FB-LRx
Purpose of Study
The purpose of this study is to evaluate the effectiveness and safety of IONIS-FB-LRx, an antisense inhibitor of complement factor B messenger ribonucleic acid (CFB mRNA), and to evaluate the effect of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in participants with primary immunoglobulin A (IgA) nephropathy.
Eligibility
Age:
18 - 75Sex:


Key Inclusion / Exclusion Criteria
Inclusion Criteria
Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal OR use a highly effective method of birth control
Biopsy-proven primary immunoglobulin A (IgA) nephropathy
Hematuria
Proteinuria
Exclusion Criteria
Clinically significant abnormalities in medical history (e.g., dementia, stroke, acute coronary syndrome, thrombocytopenia, or major surgery within 3 months of Screening)
Diagnosis of primary or secondary immunodeficiencies of B-lymphocyte function, splenectomy, or history of recurrent meningococcal disease
Active infection 30 days prior to study
Estimated glomerular filtration rate (eGFR) ≤ 40 milliliters per minute per 1.73 square meters (mL/min/1.73m^2) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
Presence of another renal disease including, but not limited to, diabetes and/or diabetic nephropathy, thin basement membrane disease, Alport’s disease, IgA Nephritis (Henoch-Schonlein purpura), lupus nephritis, Minimal Change Disease, post-infectious glomerulonephritis or any other cause of proteinuria or secondary IgA nephropathy (including, but not limited to Celiac disease, Crohn’s disease, human immunodeficiency virus (HIV), liver cirrhosis)
History of renal transplant or another organ transplant
Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of investigational agent, whichever is longer
Administration of immunosuppressive/immunomodulatory medication 12 months prior to study drug administration, except for short-term treatments.
Other protocol-specified inclusion/exclusion criteria may apply
Conditions:
Primary IgA Nephropathy
Status:
Recruiting
Phase:
Phase 2
Clinical Trials ID
NCT04014335
Read Detailed Summary:
Start Date / End Date:
12 2019 - 12 2023
Intervention:
IONIS-FB-LRx
Enrollment:
25
Full Details:
7 Study Locations
Australia
IONIS Investigative Site
Liverpool, New South Wales, 2170
Australia
email: [email protected]
phone: (02) 8738 3710
IONIS Investigative Site
St Leonards, New South Wales, 2065
Australia
email: [email protected]
phone: (04) 5756 7527
IONIS Investigative Site
Parkville, Victoria, 3050
Australia
email: [email protected]
phone: (03) 9342 8530
Canada
IONIS Investigative Site
Vancouver, British Columbia, V6Z 1Y6
Canada
email: [email protected]
phone: 604-806-9460
IONIS Investigative Site
Toronto, Ontario, M4G 3E8
Canada
email: [email protected]
phone: 416-480-6100 x 83705
New Zealand
IONIS Investigative Site
Christchurch, 8011
New Zealand
email: [email protected]
phone: +64 (0) 3 3729 477