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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04014335


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04014335
Ethics application status
Date submitted
8/07/2019
Date registered
10/07/2019

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
ISIS 696844-CS4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary IgA Nephropathy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IONIS-FB-LRx

Experimental: IONIS-FB-LRx -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Reduction in 24-hour Urine Protein Excretion
Timepoint [1] 0 0
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 [1] 0 0
Absolute Reduction in 24-hour Urine Protein Excretion
Timepoint [1] 0 0
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 [2] 0 0
Absolute Reduction in Albuminuria (UACr Ratio)
Timepoint [2] 0 0
Baseline to Week 29
Secondary outcome [3] 0 0
Absolute Reduction in Proteinuria (UPCr Ratio)
Timepoint [3] 0 0
Baseline to Week 29
Secondary outcome [4] 0 0
Percent Change from Baseline in Plasma Factor B (FB)
Timepoint [4] 0 0
Up to Week 29
Secondary outcome [5] 0 0
Percent Change from Baseline in Plasma AH50
Timepoint [5] 0 0
Up to Week 29

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/04/2024
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
IONIS Investigative Site - Liverpool
Recruitment hospital [2] 0 0
IONIS Investigative Site - St Leonards
Recruitment hospital [3] 0 0
IONIS Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
Singapore
State/province [4] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ionis Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04014335

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
Recruiting in New Zealand
Province(s)/district(s)
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Ionis Pharmaceuticals
Primary sponsor address
2855 Gazelle Court, Carlsbad, CA 92010
Primary sponsor country
United States of America
Ethics approval
Ethics application status
Approved
 
Public notes

Contacts
Principal investigator
Title 85 0
Name 85 0
Address 85 0
Country 85 0
Phone 85 0
Fax 85 0
Email 85 0
Contact person for public queries
Title 86 0
Name 86 0
Address 86 0
Country 86 0
Phone 86 0
Fax 86 0
Email 86 0
Contact person for scientific queries
Title 87 0
Name 87 0
Address 87 0
Country 87 0
Phone 87 0
Fax 87 0
Email 87 0