Status:
COMPLETED
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
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Primary IgA Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 o...
Detailed Description
This is a Phase 2, single arm open-label clinical study in up to 25 participants that will consist of a screening period, a 24-week treatment period, an optional treatment extension period of up to an...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04014335
Start Date
December 4 2019
End Date
April 11 2024
Last Update
January 23 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
IONIS Investigative Site
Liverpool, New South Wales, Australia, 2170
2
IONIS Investigative Site
St Leonards, New South Wales, Australia, 2065
3
IONIS Investigative Site
Parkville, Victoria, Australia, 3050
4
IONIS Investigative Site
Vancouver, British Columbia, Canada, V6Z 1Y6