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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04014335
Other study ID # ISIS 696844-CS4
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 4, 2019
Est. completion date April 11, 2024

Study information

Verified date May 2024
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in participants with primary immunoglobulin A (IgA) nephropathy.


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 additional 48 weeks, and a 12- week post-treatment follow-up evaluation period.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date April 11, 2024
Est. primary completion date February 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
IONIS-FB-LRx
Participants will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Week 1 and every 4 weeks through Week 25. Optional 48-week Extension, with drug dosing continuing every 4 weeks.

Locations

Country Name City State
Australia IONIS Investigative Site Liverpool New South Wales
Australia IONIS Investigative Site Parkville Victoria
Australia IONIS Investigative Site St Leonards New South Wales
Canada IONIS Investigative Site Toronto Ontario
Canada IONIS Investigative Site Vancouver British Columbia
New Zealand IONIS Investigative Site Christchurch
Singapore IONIS Investigative Site Singapore

Sponsors (1)

Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand,  Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percent Reduction in 24-hour Urine Protein Excretion Baseline to Week 29 (If participant discontinues Study Drug prior to Week 25, Baseline and 4 weeks after the last dose of Study Drug will be measured)
Secondary Absolute Reduction in 24-hour Urine Protein Excretion Baseline to Week 29 (If participant discontinues Study Drug prior to Week 25, Baseline and 4 weeks after the last dose of Study Drug will be measured)
Secondary Absolute Reduction in Albuminuria (UACr Ratio) Baseline to Week 29
Secondary Absolute Reduction in Proteinuria (UPCr Ratio) Baseline to Week 29
Secondary Percent Change from Baseline in Plasma Factor B (FB) Up to Week 29
Secondary Percent Change from Baseline in Plasma AH50 Up to Week 29
See also
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Recruiting NCT05847920 - Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy Phase 2
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Not yet recruiting NCT02712697 - Integrative Medicine of IgA Nephropathy N/A
Completed NCT04887532 - A Trial of HR19042 Capsule in Healthy Chinese Subjects Phase 1
Not yet recruiting NCT06137768 - A Trial of HRS-5965 Tablets in Primary IgA Nephropathy Phase 2
Completed NCT02351752 - Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study Phase 4
Completed NCT01738035 - The Effect of Nefecon® in Patients With Primary IgA Nephropathy at Risk of Developing End-stage Renal Disease Phase 2
Recruiting NCT05797610 - A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression Phase 3