At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Sefaxersen (RO7434656) (drug), Placebo (drug)
- How long the study runs
- Study runs about 72 months (dates as stated)
- About the drug or intervention
- Sefaxersen (RO7434656) — drug: Sefaxersen (RO7434656) will be administered as SC injection per schedule as specified in the protocol. · Placebo — drug: Matching placebo will be administered as SC injection per schedule as specified in the protocol.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 459
- Started
- 2023-08-08
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for primary iga nephropathy
- • Phase3 - 459 participants
- • The purpose of this study is to evaluate the efficacy, safety, \& pharmacokinetics of sefaxersen (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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with primary iga nephropathy
Where?
- • Cambridge - Addenbrookes Hospital
- • Leicester - Leicester General Hospital
- • London - Guys and St Thomas Hospital
- • London - Kings College Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the efficacy, safety, \& pharmacokinetics of sefaxersen (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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Primary IgAN, as evidenced by a kidney biopsy performed within 10 years prior to or during screening, without known...
- ✓eGFR ≥ 20 mL/min/1.73 m\^2, as calculated by the 2021 CKD-EPI creatinine equation (Inker et al. 2021a)
- ✓Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to...
- ✓Female participants of childbearing potential must use adequate contraception
Who cannot take part
- ✗Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final...
- ✗Histopathologic or other evidence of another autoimmune glomerular disease
- ✗Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of kidney blood test within 3 months prior to...
- ✗History of kidney transplantation
- ✗Glycated red blood cell level (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type
See the full criteria
Where Is This Study? (6 UK sites)
Addenbrookes Hospital
Cambridge CB2 0QQ, United Kingdom
Leicester General Hospital
Leicester LE5 4PW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Guys and St Thomas Hospital
London SE1 9RT, United Kingdom
Kings College Hospital
London SE5 9RS, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
Salford Royal Hospital
Salford M6 8HD, United Kingdom
