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ACTIVE NOT RECRUITINGPhase3

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

Sponsor: Hoffmann-La Roche

NCT ID: NCT05797610

View on ClinicalTrials.gov ↗

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.

Primary IgA Nephropathy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

eGFRCD20

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
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, 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 * 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 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 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 millimetre of mercury (mmHg) or diastolic blood pressure \>90 mmHg from the average of two measurements performed at least 1 minute apart during screening * Initiation of sodium-glucose cotransporter-2 (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 Glucagon-like Peptide-1 (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

Where Is This Study? (6 UK sites)

Addenbrookes Hospital

Cambridge CB2 0QQ, United Kingdom

Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Leicester General Hospital

Leicester LE5 4PW, United Kingdom

Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Guys and St Thomas Hospital

London SE1 9RT, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Kings College Hospital

London SE5 9RS, United Kingdom

Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Salford Royal Hospital

Salford M6 8HD, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09