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. 2023 Sep 29;8(12):2822–2825. doi: 10.1016/j.ekir.2023.09.026

Table 1.

Key inclusion and exclusion criteria

Inclusion Criteria
All patients
  • -

    Male and female patients aged 18–75 years with signed and dated informed consent

  • -

    Biopsy-proven primary FSGS or documented TRPC6 gene mutation causing FSGS

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    Mean UPCR ≥1000 mg/g

  • -

    BMI ≤40 kg/m2

Corticosteroid therapy
  • -

    Stable dose for ≥4 weeks (if applicable)

ACEi/ARB/finerenone/ASI/SGLT2i treatment
  • -

    Stable dose for ≥4 weeks prior to screening, with no plan to change dose


Exclusion criteria

Diagnosis
  • -

    Known monogenic FSGS (except TRPC6) or clinical/histological evidence of secondary FSGS

  • -

    Documented Alport syndrome, nail patella syndrome, diabetic nephropathy, IgA nephropathy, lupus nephritis, monoclonal gammopathy

  • -

    Genitourinary malformations with vesicoureteral reflux or kidney dysplasia

  • -

    History of organ transplantation or planned transplantation during the study

  • -

    Uncontrolled hypertension (mean resting systolic blood pressure >160 mm Hg)

  • -

    QTc intervals >450 ms in men or >470 ms in women

  • -

    History of congenital long QT syndrome, previous drug-induced QT prolongation, or other risk factors for torsade de pointes

  • -

    Graded cataracts

  • -

    History of gastrointestinal surgery or disorders that could interfere with trial mediation absorption

  • -

    History of relevant allergy or hypersensitivity according to the investigator’s clinical judgment

Concomitant therapy
  • -

    Calcineurin inhibitors

  • -

    Cytotoxic agents (cyclophosphamide, chlorambucil) or CD20 monoclonal antibodies (e.g., rituximab) within five half-lives before screening

  • -

    Metformin, dofetilide, dabigatran, or digoxin within 5 half-lives before screening

  • -

    Strong inhibitors or inducers of CYP3A within 1 week or 5 half-lives before screening

Safety laboratory findings
  • -

    eGFR <30 ml/min/1.73 m2

  • -

    ALT/AST >3 × ULN at screening

ACEi, angiotensin-converting enzyme inhibitor; ALT, alanine aminotransferase; ARB, angiotensin receptor blocker; ASI, aldosterone synthase inhibitor; AST, aspartate aminotransferase; BMI, body mass index; eGFR, estimated glomerular filtration rate; FSGS, focal segmental glomerulosclerosis; IgA, immunoglobulin A; SGLT2i, sodium-glucose cotransporter-2 inhibitor; TRPC6, transient receptor potential cation channel, subfamily C, member 6; ULN, upper limit of normal; UPCR, urinary protein:creatinine ratio.