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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
Date last updated
10/10/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of 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 - RO7434656
Treatment: Drugs - Placebo

Experimental: RO7434656 - Participants will receive subcutaneous (SC) doses of RO7434656 on Days 1, 15, and 29 followed by once every 4 weeks until Week 105. After Week 105, participants may continue blinded treatment or enter open-label treatment until up to 1 year after the date at which the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.

Placebo comparator: Placebo - Participants will receive SC doses of RO7434656 matching placebo on Days 1, 15, and 29 followed by once every 4 weeks until Week 105. After Week 105, participants may continue blinded treatment or enter open-label treatment until up to 1 year after the date at which the last participant completes the Week 105 assessment, withdraws, or is discontinued from the study.


Treatment: Drugs: RO7434656
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 RO7434656
Timepoint [5] 0 0
Up to approximately 7 years

Eligibility
Key inclusion criteria
* Primary IgAN, as evidenced by a kidney biopsy performed within 7 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
* 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 obtained no longer than 60 days prior to Day 1
* 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)
* 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 RO7434656
* 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
* Glycated Hemoglobin (HbA1c) = 6.5% or a clinical diagnosis of diabetes mellitus of any type
* Uncontrolled blood pressure, in the investigator's assessment, for 3 months prior to screening or during screening
* Use of endothelin receptor antagonists, except those approved for use in IgAN
* Initiation of mineralocorticoid receptor antagonists or endothelin receptor antagonists within 90 days prior to screening or during screening
* Previous treatment with RO7434656
* Use of herbal therapies within 90 days prior to or during screening
* 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 other immunomodulatory agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), or mycophenolate
* Treatment with a calcineurin inhibitor within 2 months prior to screening or during screening
* Treatment with anti-CD20 therapy within 9 months of 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
* Planned major procedure or major surgery during screening or the study

Other protocol-defined inclusion/exclusion criteria may apply

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
5000 - 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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Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.
Trial website
https://clinicaltrials.gov/study/NCT05797610
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05797610