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NCT04014335CompletedPhase 2

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

An Open-Label Phase 2a Clinical Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Subjects With Primary IgA Nephropathy

Source: ClinicalTrials.gov · Last updated 23 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
23 (actual)
First submitted
8 Jul 2019
Start date
4 Dec 2019
Primary completion date
8 Feb 2024
Lead sponsor
Ionis Pharmaceuticals, Inc.
NCT number
NCT04014335

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 23
  • From 4 Dec 2019 to the primary completion date, 8 Feb 2024
  • 7 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active infection 30 days prior to study
  • 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 illness

  • Clinically significant abnormalities in medical history (e.g., dementia, stroke, acute coronary syndrome, thrombocytopenia, or major surgery within 3 months of Screening)
  • 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

Lab values

  • Diagnosis of primary or secondary immunodeficiencies of B-lymphocyte function, splenectomy, or history of recurrent meningococcal disease
  • 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)

Other

  • Other protocol-specified inclusion/exclusion criteria may apply

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IONIS Investigative Site
Coordinator of this site? Confirm its status
LiverpoolAustraliaUnknown status
IONIS Investigative Site
Coordinator of this site? Confirm its status
ParkvilleAustraliaUnknown status
IONIS Investigative Site
Coordinator of this site? Confirm its status
St LeonardsAustraliaUnknown status
IONIS Investigative Site
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
IONIS Investigative Site
Coordinator of this site? Confirm its status
VancouverCanadaUnknown status
IONIS Investigative Site
Coordinator of this site? Confirm its status
ChristchurchNew ZealandUnknown status
IONIS Investigative Site
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.