Voclosporin in Adolescents With Lupus Nephritis
About the study
Who can take part
INCLUSION CRITERIA
Key Inclusion Criteria:
- Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
- Subjects with kidney biopsy confirmed active lupus nephritis.
EXCLUSION CRITERIA
Exclusion Criteria:
- Estimated glomerular filtration rate (eGFR) <60 mL/minute/1.73 m2 at screening.
- Current or medical history of:
- Congenital or acquired immunodeficiency.
- Clinically significant drug or alcohol abuse prior to screening.
- Malignant neoplasm.
- Lymphoproliferative disease or previous total lymphoid irradiation.
- Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening.
- Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
- Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes.
- Currently taking or known need for any of the following medications:
* Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.
Study Locations
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How to Apply
Study Details
Contition
Adolescent Lupus Nephritis
Age
12 - 17
Phase
PHASE3
Participants Needed
40
Est. Completion Date
Jan 31, 2025
Treatment Type
INTERVENTIONAL
Sponsor
Aurinia Pharmaceuticals Inc.
ClinicalTrials.gov NCT Identifier
NCT05288855
Study Number
AUR-VCS-2020-03
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