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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05248646




Registration number
NCT05248646
Ethics application status
Date submitted
18/02/2022
Date registered
21/02/2022
Date last updated
10/07/2025

Titles & IDs
Public title
Visionary Study: Phase 3 Trial of Sibeprenlimab in Immunoglobulin A Nephropathy (IgAN)
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Secondary ID [1] 0 0
417-201-00007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immunoglobulin A 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 - Sibeprenlimab 400 mg
Treatment: Drugs - Placebo

Active comparator: Sibeprenlimab 400 mg s.c. q 4weeks -

Placebo comparator: Placebo -


Treatment: Drugs: Sibeprenlimab 400 mg
Sibeprenlimab 400 mg s.c. q 4 weeks

Treatment: Drugs: Placebo
Placebo s.c. q 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Urinary protein to creatinine ratio (uPCR) in a 24-hour collection
Timepoint [1] 0 0
At 9 months
Secondary outcome [1] 0 0
Annualized rate of change from baseline (slope) of eGFR
Timepoint [1] 0 0
Over 24 months
Secondary outcome [2] 0 0
Proportion of subjects achieving urine total protein < 1.0 g/day and = 25% reduction from baseline.
Timepoint [2] 0 0
At 12 months
Secondary outcome [3] 0 0
Annualized slope of eGFR
Timepoint [3] 0 0
Over 12 months

Eligibility
Key inclusion criteria
* Male and female patients = 18 years of age .
* Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
* Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated =3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
* Screening urine protein/creatinine ratio (uPCR) = 0.75 g/g or urine protein = 1.0 g/day
* eGFR = 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the CKD-EPI equation.)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Secondary forms of IgAN or IgA vasculitis.
* Coexisting chronic kidney disease other than IgAN.
* Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
* Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
* Nephrotic syndrome
* Serum IgG < 600 mg/dL at screening.
* Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
* Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
* Chronic infectious disease, or acute infectious disease at time of screening.
* Type 1 diabetes, or poorly controlled Type 2 diabetes
* Uncontrolled hypertension

The protocol provides additional information about these and other inclusion and exclusion criteria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
Accrual to date
Final
530
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Site #3 - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Site #13 - Concord
Recruitment hospital [3] 0 0
St. George Hospital - Site #14 - Kogarah
Recruitment hospital [4] 0 0
University of New South Wales (UNSW) - Liverpool Hosp - Site #11 - Liverpool
Recruitment hospital [5] 0 0
John Hunter Hospital - Site #5 - New Lambton Heights
Recruitment hospital [6] 0 0
Prince of Wales Hospital - Site #2 - Randwick
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Site #6 - Saint Leonards
Recruitment hospital [8] 0 0
Royal Adelaide Hospital - Site #12 - Adelaide
Recruitment hospital [9] 0 0
Flinders Medical Centre - Site #9 - Bedford Park
Recruitment hospital [10] 0 0
Launceston General Hospital - Site #8 - Launceston
Recruitment hospital [11] 0 0
The University of Melbourne - St. Vincent's Hospital Melbourne (SVHM) - Site #1 - Fitzroy
Recruitment hospital [12] 0 0
Western Health Sunshine Hospital - Site #10 - St Albans
Recruitment hospital [13] 0 0
Fiona Stanley Hospital (FSH) - Site #4 - Murdoch
Recruitment hospital [14] 0 0
Sir Charles Gairdner Hospital - Site #7 - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2139 - Concord
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2217 - Kogarah
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2170 - Liverpool
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2305 - New Lambton Heights
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2031 - Randwick
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2065 - Saint Leonards
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5000 - Adelaide
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5042 - Bedford Park
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7250 - Launceston
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3065 - Fitzroy
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3021 - St Albans
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment outside Australia
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Hu?

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Otsuka Pharmaceutical Development & Commercialization, 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


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/NCT05248646