Nephrology: Clinical Studies Open For Enrollment
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Eligibility
- Male or Female, Age ≥18 years (or ≥ legal age within the country if it is older than 18 years) ≤ 75 years of age.
- Diagnosis of SLE and LN according to 2019 European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) classification criteria.
- Participant must be positive for at least one of the following autoantibodies at screening (performed by central laboratory) or through documented history:
- antinuclear antibodies (ANA) ≥ 1:80 OR
- anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range (ie, positive results) OR
- anti-Smith antibodies elevated to above normal (ie, positive results).
- Active, biopsy-proven, proliferative lupus nephritis demonstrating Class III or Class IV with or without co-existing features of Class V lupus nephritis according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria. The local biopsy report will be used.
- Inadequate response, loss of response or intolerance to at least two (2) immunosuppressive therapies, which may include MMF (or mycophenolic acid analogs [MPAA]), cyclophosphamide, belimumab, calcineurin inhibitors, AZA, or leflunomide at the maximally tolerated doses as recommended by the KDIGO guidelines (KDIGO, 2024).
Inadequate response is defined as: UPCR ≥ 1.0 mg/mg. - Exclusion Criteria
- Estimated glomerular filtration rate (eGFR) of < 30 mL per minute per 1.73 m2 of body surface area (calculated using the Modification of Diet in Renal Disease [MDRD] formula with screening laboratory results for serum creatinine value).
- Significant likely irreversible organ damage related to SLE (eg, end-stage renal disease).
- Any acute, severe lupus-related flare during screening that needs immediate treatment.
- A previous kidney transplant or planned transplant within the study treatment period.
- History of or current renal disease (other than LN) that, in the opinion of the investigator, could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
- Renal biopsy showing pure Class V.
Enrollment Status: Enrolling
Study Information
ClinicalTrials.gov | NCT06570798
Principal Investigator
Savneek Chugh, MD
Contact for Study Screening