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    Phase III: Sefaxersen in Primary IgA Nephropathy (IMAGINATION)

    Clinical Trial Overview Inclusion and Exclusion Criteria Study Site Locations Enrollment and Resources
    Clinical Trial Overview

    Clinical Trial Overview

    Recruiting

    A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled 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

    Objective

    The purpose of this study is to evaluate the efficacy, safety, and 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 Endpoints

    • Change From Baseline in the Urine Protein-to-Creatinine Ratio (UPCR) at Week 37

    Secondary Endpoints

    • Estimated Glomerular Filtration Rate (eGFR) Slope at Week 105 from Baseline
    • Time to the Composite Kidney Failure Endpoint
    • Change From Baseline in Fatigue at Week 105
    • Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs)
    • Plasma Concentration of Sefaxersen

    Sefaxersen

    Other names: IONIS-FB-LRx

    Modality: Antisense oligonucleotide that targets factor B

    Disease/Condition: Primary IgA Nephropathy

    View Molecule

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT05797610

    View on ClinicalTrials.gov
    Inclusion and Exclusion Criteria

    Inclusion and Exclusion 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 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

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT05797610

    View on ClinicalTrials.gov
    Study Site Locations

    Study Site Locations

    Explore the map to find active sites closest to your location or search by your ZIP code.

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT05797610

    View on ClinicalTrials.gov

    40 Results

      Enrollment and Resources

      Enrollment & Resources

      Enrollment

      For more information on eligibility criteria, view the study or reach out to our team.

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      Phone

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      (US and Canada)

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      Email icon

      Email

      [email protected]

      Email Us

      ADDITIONAL RESOURCES

      Contact an MSL
      Submit Medical Inquiry
      View Related Clinical Trials

      ID: NCT05797610

      View on ClinicalTrials.gov

      Resources

      ClinicalTrials.gov

      Learn more about this trial (NCT05797610) on ClinicalTrials.gov.

      Visit CT.gov

      Patient Resources

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      Information is consistent with ClinicalTrials.gov as of June 02, 2026. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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      • AD
        Alzheimer's disease

      • ABC
        advanced breast cancer

      • bADLs
        Basic activities of daily living

      • ISLT
        International Shopping List Test

      • MCI
        Mild cognitive impairment

      • CV
        coefficient of variation

      • HEX
        cell hexagonality

      • nAMD
        neurovascular age-related macular degeneration

      • PDS
        Port Delivery System

      • Q24W
        once every 24 weeks

      • BMI
        Body mass index

      • HbA1c
        Hemoglobin A1c), also called glycated hemoglobin

      • HOMA-IR
        Homeostasis Model Assessment of Insulin Resistance

      • NLM
        National Library of Medicine

      • QUICKI
        Quantitative Insulin Sensitivity Check Index

      • SC
        Subcutaneous

      • SGLT-2
        sodium-glucose cotransporter-2

      • SMBG
        Self-Monitored Blood Glucose

      • T1DM
        Type 1 Diabetes Mellitus

      • T2DM
        Type 2 diabetes mellitus

      • AE
        adverse events

      • AESI
        Adverse Events of Special Interest

      • MDD
        major depressive disorder

      • PHQ-9
        Patient Health Questionnaire-9

      • SAE
        serious adverse events

      • ABR
        Annualized Bleed Rate

      • CBR
        clinical benefit rate

      • CDK4/6i
        cyclin-dependent kinase 4 and 6 inhibitor

      • CNS
        central nervous system

      • CR
        complete response

      • DoR
        duration of response

      • ER
        estrogen receptor

      • HER2
        human epidermal growth factor receptor 2

      • HER2-
        human epidermal growth factor receptor 2-negative

      • HR
        hormone receptor

      • HR+
        hormone receptor-positive

      • HRQoL
        health-related quality of life

      • mut
        mutated

      • NIS
        non-interventional study

      • ORR
        objective response rate

      • OS
        overall survival

      • PFS
        progression-free-survival

      • PIK3CA
        phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

      • PIK3CAm
        PIK3CA-mutated

      • PK
        pharmacokinetics

      • PROs
        patient-reported outcomes

      • SD
        stable disease

      • SoC
        standard of care

      • VWD
        von Willebrand disease

      • WHO
        World Health Organization

      • T2D
        Type 2 diabetes

      • T1D
        Type 1 Diabetes

      • ADA
        anti-drug antibody

      • DXA
        Dual-energy X-ray Absorptiometry

      • ASCVD
        atherosclerotic cardiovascular disease

      • FGF21
        fibroblast growth factor 21

      • SHTG
        severe hypertriglyceridemia

      • TG
        triglycerides

      • MASH
        metabolic dysfunction-associated steatohepatitis

      • NAFLD
        non-alcoholic fatty liver disease

      • NAS
        NAFLD Activity Score

      • NASH
        nonalcoholic steatohepatitis

      • pmMS
        partial modified Mayo

      • CD
        Crohn's disease

      • CMV
        cytomegalovirus

      • HIV
        human immunodeficiency virus

      • HBV
        Hepatitis B

      • HCV
        Hepatitis C

      • TB
        tuberculosis

      • UC
        ulcerative colitis

      • TL1A
        tumor necrosis factor-like ligand 1A

      • mMS
        modified Mayo Score

      • APS
        average daily abdominal pain scores in the past week

      • CDAI
        Crohn’s Disease Activity Index

      • IBDQ
        Inflammatory Bowel Disease Questionnaire

      • SF
        stool frequency subscore

      • PBO
        Placebo

      • EASI
        Eczema Area and Severity Index

      • IGA
        Investigator Global Assessment

      • NRS
        Numerical Rating Scale

      • IM
        intramuscular

      • IL
        intralesional

      • PDE-4
        Phosphodiesterase-4

      • ACE
        angiotensin-converting enzyme

      • ARBs
        angiotensin II receptor blockers

      • ASO
        Antisense Oligonucleotide

      • CKD-EPI
        Chronic Kidney Disease Epidemiology Collaboration

      • eGFR
        Estimated Glomerular Filtration Rate

      • FACIT-F
        Functional Assessment of Chronic Illness Therapy-Fatigue subscale

      • g/day
        gram per day

      • g/g
        gram per gram

      • GIP
        Glucose-dependent Insulinotropic Polypeptide

      • GLP-1
        Glucagon-like Peptide-1

      • IgAN
        IgA nephropathy

      • mg/day
        milligrams per day

      • TEAEs
        Treatment-Emergent Adverse Events

      • UPCR
        Urine Protein-to-Creatinine Ratio

      • AEs
        Adverse events

      • ALT
        Alanine aminotransferase

      • AST
        Aspartate aminotransferase

      • C-SSRS
        Columbia-Suicide Severity Rating Scale

      • DMT
        Disease-modifying therapy

      • ECG
        Electrocardiogram

      • EDSS
        Expanded Disability Status Scale

      • Gd
        Gadolinium

      • IPMSSG
        International Pediatric Multiple Sclerosis Study Group

      • MRI
        Magnetic resonance imaging

      • MS
        Multiple sclerosis

      • PD
        Pharmacodynamic

      • PPMS
        Primary progressive multiple sclerosis

      • RMS
        Relapsing multiple sclerosis

      • SI
        Suicidal ideation

      • SPMS
        Secondary progressive multiple sclerosis

      • CYP3A4
        cytochrome-p450-3a4

      • ADAS-Cog-13
        Alzheimer's Disease Assessment Scale-Cognition 13

      • ADAs
        Anti-drug antibodies

      • ADCS-ADL
        Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory

      • ARIA
        Amyloid-related imaging abnormalities

      • CDR-GS
        Clinical Dementia Rating, Global Score

      • CDR-SB
        Clinical Dementia Rating, Sum of Boxes

      • CSF
        Cerebrospinal fluid

      • GFAP
        Glial fibrillar acidic protein

      • iADRS
        Integrated Alzheimer's Disease Rating Scale

      • IRR
        Infusion-related reactions

      • MMSE
        Mini-Mental State Examination

      • PET
        Positron emission tomography

      • RBANS DMI
        Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index

      • EORTC QLQ-C30
        European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire

      • PRO-CTCAE
        Patient-Reported Outcomes Common Terminology Criteria for Adverse Events

      • TTCD
        Time to Confirmed Deterioration

      • AJCC
        American Joint Committee on Cancer Staging System

      • ECOG
        Eastern Cooperative Oncology Group

      • FFPE
        formalin-fixed, paraffin-embedded

      • RECIST
        Response Evaluation Criteria in Solid Tumors

      • NSCLC
        non-small cell lung cancer

      • BICR
        blinded independent central review

      • CD137
        Cluster of Differentiation 137

      • EORTC QLQ-LC13
        European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module

      • KRAS G12C
        Kirsten rat sarcoma viral oncogene homolog G12C

      • PD-L1
        Programmed death-ligand 1

      • RAS
        RAt Sarcoma

      • RT
        Radiation therapy

      • DOCR
        duration of complete response

      • DFS
        disease-free survival

      • EFSeff
        event-free survival efficacy causes

      • FACT-Lym LymS
        lymphoma subscale within the functional assessment of cancer therapy-Lymphoma questionnaire

      • IPI
        international prognostic index

      • IRF
        Independent Review Facility

      • Pola-R-CHP
        polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone

      • LBCL
        large B-cell lymphoma

      • PROMIS-29
        Patient-Reported Outcomes Measurement Information System-29

      • ESR1nmd
        ESR1 no-mutation-detected

      • IV
        intravenous

      • II
        2

      • ECD
        endothelial cell density

      • III
        3

      +