Lupus Nephritis
Conditions
Interventions
Voclosporin will be administered orally at a dose of 23.7 mg twice daily for a duration of 24 weeks. Dose reduction may be implemented as appropriate based on the patient's condition.
Sponsors
furuhashi kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients who understand the study details and provided written informed consent to participate in the study of their own free will. (2)Patients aged between 18 and 75 years at the time of obtaining informed consent. (3)Patients diagnosed with SLE according to the ACR or SLICC classification criteria. (4)Patients in the induction phase of remission as defined in the SLE treatment guidelines. (5)Patients whose renal biopsy results obtained within 2 years prior to consent indicate LN classified as Class III, IV, III+V, or IV+V according to ISN/RPS criteria. (6)Patients with a UPCR of >=0.5 mg/mg or daily urinary protein excretion of >=0.5 g/day. (7)Patients who have received or are scheduled to receive intravenous methylprednisolone (IVMP) between Day -84 and Day -1. (8)Patients scheduled to receive MMF for at least one week prior to Day 1.
Exclusion criteria
Exclusion criteria: (1)Patients with a history of hypersensitivity to any component of Lupkynis capsules 7.9 mg. (2)Patients undergoing maintenance hemodialysis or peritoneal dialysis. (3)Patients with a history of kidney transplantation. (4)Patients with serious comorbidities, such as: Active infections Cardiac diseases Poorly controlled diabetes or hypertension Interstitial pneumonia Pulmonary fibrosis Active malignancies (5)Patients with type 1 diabetes or poorly controlled type 2 diabetes (Hemoglobin A1c >=8%). (6)Female patients who are pregnant, breastfeeding, or intending to become pregnant. (7)Patients with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, calculated using the CKD-EPI formula. (8)Patients who have received calcineurin inhibitors (CNi) within 12 weeks prior to obtaining informed consent. (9)Patients who have received any of the following medications within 24 weeks prior to enrollment: Rituximab Belimumab (10)Patients whose dosage or administration of hydroxychloroquine (HCQ) has been changed after obtaining informed consent. (11)Patients participating in any other clinical trial or clinical study (excluding studies involving approved products). (12)Patients deemed inappropriate for participation in this study by the principal or sub-investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes in RNA expression levels before initiation of VCS administration, and at 4 and 12 weeks post-initiation, will be analyzed based on prior studies to evaluate the impact of VCS on immune cells. | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation between clinical efficacy, as assessed by urinary protein-to-creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR) at the initiation of VCS administration and at Week 12, and changes in RNA levels will be evaluated. The mechanism of action (MOA) of VCS will be explored by examining the relationships among peripheral immune cell populations and transcriptional regulators, based on changes in RNA expression patterns observed at the initiation of VCS administration, and at Weeks 4 and 12. Adverse events (AEs), serious adverse events (SAEs), non-serious adverse events, and disease-related events will be assessed. | — |
Contacts
Public ContactEri Koshi
Nagoya University Hospital
Outcome results
None listed