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Trial record 1 of 1 for:    NCT04014335 | IgA Nephropathy
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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

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ClinicalTrials.gov Identifier: NCT04014335
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Primary IgA Nephropathy Drug: IONIS-FB-LRx Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 4, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: IONIS-FB-LRx 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.




Primary Outcome Measures :
  1. Percent Reduction in 24-hour Urine Protein Excretion [ Time Frame: 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 Outcome Measures :
  1. Absolute Reduction in 24-hour Urine Protein Excretion [ Time Frame: 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) ]
  2. Absolute Reduction in Albuminuria (UACr Ratio) [ Time Frame: Baseline to Week 29 ]
  3. Absolute Reduction in Proteinuria (UPCr Ratio) [ Time Frame: Baseline to Week 29 ]
  4. Percent Change from Baseline in Plasma Factor B (FB) [ Time Frame: Up to Week 29 ]
  5. Percent Change from Baseline in Plasma AH50 [ Time Frame: Up to Week 29 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014335


Contacts
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Contact: Ionis Pharmaceuticals (844) 727-6672 ionisNCT04014335study@clinicaltrialmedia.com

Locations
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Australia, New South Wales
IONIS Investigative Site Recruiting
Liverpool, New South Wales, Australia, 2170
IONIS Investigative Site Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Victoria
IONIS Investigative Site Recruiting
Parkville, Victoria, Australia, 3050
Canada, British Columbia
IONIS Investigative Site Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
IONIS Investigative Site Recruiting
Toronto, Ontario, Canada, M4G 3E8
New Zealand
IONIS Investigative Site Recruiting
Christchurch, New Zealand, 8011
Singapore
IONIS Investigative Site Recruiting
Singapore, Singapore, 168582
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04014335    
Other Study ID Numbers: ISIS 696844-CS4
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases