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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05797610




Registration number
NCT05797610
Ethics application status
Date submitted
22/03/2023
Date registered
4/04/2023

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
Scientific title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RO7434656, an Antisense Inhibitor of Complement Factor B, in Patients With Primary IgA Nephropathy at High Risk of Progression
Secondary ID [1] 0 0
2022-502102-32-00
Secondary ID [2] 0 0
WA43966
Universal Trial Number (UTN)
Trial acronym
IMAGINATION
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 - sefaxersen (RO7434656)
Treatment: Drugs - Placebo

Experimental: sefaxersen (RO7434656) - Participants will receive subcutaneous (SC) doses of sefaxersen (RO7434656) on Days 1, 15, and 29 followed by once every 4 weeks until Week 105. Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.

Placebo comparator: Placebo - Participants will receive SC doses of sefaxersen (RO7434656) matching placebo on Days 1, 15, and 29 followed by once every 4 weeks until Week 105. Participants may be eligible to switch to open-label treatment after Week 105 at the investigator's discretion until up to 1 year after the common-close timepoint, the date when the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.


Treatment: Drugs: sefaxersen (RO7434656)
Sefaxersen (RO7434656) will be administered subcutaneously per schedule as specified.

Treatment: Drugs: Placebo
Matching placebo will be administered subcutaneously per schedule as specified.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37
Timepoint [1] 0 0
Baseline, Week 37
Secondary outcome [1] 0 0
Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
Timepoint [1] 0 0
Baseline, Week 105
Secondary outcome [2] 0 0
Time to the Composite Kidney Failure Endpoint
Timepoint [2] 0 0
Up to approximately 7 years
Secondary outcome [3] 0 0
Change From Baseline in Fatigue at Week 105
Timepoint [3] 0 0
Baseline, Week 105
Secondary outcome [4] 0 0
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
Timepoint [4] 0 0
Up to approximately 7 years
Secondary outcome [5] 0 0
Plasma Concentration of sefaxersen
Timepoint [5] 0 0
Up to approximately 7 years

Eligibility
Key inclusion criteria
* Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known secondary cause
* Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening, except for interruptions due to illness (not greater than 7 consecutive days), unless the potential participant is intolerant to these medications
* Urine Protein-to-Creatinine Ratio (UPCR) = 1 gram per gram (g/g) or urine protein excretion = 1 gram per day (g/day) (with UPCR = 0.8 g/g), all measured from a 24-hour urine collection during screening
* eGFR = 20 mL/min/1.73 m^2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (Inker et al. 2021a)
* Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to national vaccination recommendations
* Female participants of childbearing potential must use adequate contraception
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of sefaxersen
* Histopathologic or other evidence of another autoimmune glomerular disease
* Presence of = 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator
* History of kidney transplantation
* Glycated Hemoglobin (HbA1c) = 6.5% or a clinical diagnosis of diabetes mellitus of any type
* Systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg from the average of two measurements performed at least 1 minute apart during screening
* Initiation of SGLT2 inhibitors within 16 weeks prior to screening or during screening
* Initiation of endothelin receptor antagonists within 90 days prior to screening or during screening
* Initiation of mineralocorticoid receptor antagonists or non-dihydropyridine calcium channel blockers within 90 days prior to screening or during screening
* Use of herbal therapies within 90 days prior to or during screening
* Treatment with investigational therapy within 28 days prior to screening or 5.5 drug-elimination half-lives of that investigational product prior to screening
* Treatment with an investigational therapy planned during the treatment period
* Previous treatment with sefaxersen
* Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to = 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to = 5 mg/day of prednisone for 14 days within 90 days prior to screening
* Treatment with corticosteroids with systemic effects during screening
* Treatment with a systemic calcineurin inhibitor within 2 months prior to screening or during screening
* Treatment with anti-CD20 therapy within 9 months of screening or during screening
* Treatment with other systemic immunosuppressive agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), azathioprine, or mycophenolate
* Planned major procedure or major surgery during screening or the study
* Substance abuse within 12 months prior to screening or during screening
* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
* History of malignancy within < 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Usage of GLP-1-based therapy (i.e., GLP-1 mono-agonists, GLP-1/GIP dual agonists, etc.) within 90 days prior to screening or during screening, or intent to initiate during the study period

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 administering the treatment/s
The people assessing the outcomes
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2030
Actual
Sample size
Target
428
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [7] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
02747 - Kingswood
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
SA5000 - Adelaide
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
WA43966 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. Only)
Fax 0 0
Email 0 0
[email protected]
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/NCT05797610