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A Study to Evaluate the Efficacy and Safety of Sefaxersen, an Antisense Inhibitor of Complement Factor B, in Patients with Primary IgA Nephropathy at High Risk of Progression
EU CTIS ID: 2022-502102-32-00
What this study is testing
To evaluate the efficacy of Sefaxersen compared with placebo on the basis of change in proteinuria, as measured by the urine protein-to-creatinine ratio (UPCR) change at Week 37 from baseline from a 24-hour collection
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Primary IgA nephropathy (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 receptor blockers (ARBs) for at least 90 days immediately prior to screening, and without an intent to modify the dose during the study, except for interruptions due to illness (not greater than 7 consecutive days) ), unless the potential participant is intolerant to these medications
- UPCR ≥ 1 g/g or urine protein excretion ≥ 1 g/day (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening
- eGFR ≥ 20 mL/min/1.73 m2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
- Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment and against Streptococcus pneumoniae. Vaccination against Haemophilus influenzae according to national vaccination recommendations for patients receiving complement inhibitors
- Agree to use protocol defined methods of contraception by female participants and no contraception requirements for male participants
You likely can't join if
- 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
- Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
- Previous treatment with Sefaxersen
- History of malignancy within <5 years prior to screening
- Hemoglobin A1c ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- China
- Malaysia
- Canada
- United States
- Brazil
- Hong Kong
- Japan
- United Kingdom
- Australia
- Argentina
- Korea, Republic of
- Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; China; Malaysia; Canada; United States; Brazil and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.