A Trial to Explore the Efficacy and Safety of O-triple as Initial Therapy in the Active Lupus Nephritis Patients (INITIAL Trial)

Más betegség

• Have active gastrointestinal ulcer.

Laborértékek

• Have severe renal impairment, defined as eGFR < 30 mL/min/1.73 m² (estimated using the CKD-EPI equation), or require dialysis or renal transplantation.

Egyéb

• Are pregnant or breastfeeding.
• Have renal biopsy showing > 50% glomerular sclerosis.
• Have pure chronic renal biopsy findings: no active lesions.
• Have rapidly progressive glomerulonephritis.
• Have intolerance or contraindication to the study treatment.

• Signed Informed Consent Form
• Age 18 to 65 years at time of signing Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• ISN/RPS 2003 Class III, IV, V active/active chronic LN by renal biopsy performed within the 1 month prior to screening or during screening with 24hUPCR≥1g/g
• SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria, which are met by the presence of Class III- V LN or mixed Class LN, and current or past positive antinuclear antibody (ANA) Positive ANA is defined by ANA at a titer of ≥ 1:80 on HEp-2 cells or an equivalent positive ANA test at least once.
• Receipt of at least one dose of pulse methylprednisolone IV (≥250 mg) or equivalent for treatment of the current episode of active LN during the 1 month prior to screening or during screening
• A maximum of 3 g methylprednisolone IV or equivalent d during the 4 weeks prior to screening or during screening is allowed.