Study of Iptacopan for Active Lupus Nephritis
This study is testing a drug called iptacopan (LNP023) to see how well it works and if it's safe for people with active lupus nephritis (a kidney disease caused by lupus). Participants will receive either iptacopan or a placebo (an inactive substance) in addition to their usual care for 52 weeks. The study is looking to see how many people achieve a complete kidney response (meaning their kidneys are working much better) at 24 weeks without their lupus nephritis flaring up. You may be able to join if you are 18 to 100 years old, have active lupus nephritis (Class III or IV, possibly with Class V features) confirmed by a kidney biopsy within the last 3 months, and have specific positive blood tests (ANA and/or anti-dsDNA). The study plans to enroll 240 participants, but its current status is unclear.
- Study design
- This interventional study plans to enroll 240 participants. It involves different groups receiving iptacopan or a placebo, along with standard care.
- What's involved
- Participants will take iptacopan or placebo for 52 weeks. The primary endpoint is measured at week 24.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome is measured at week 24, but interventions continue for 52 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
At a glance
Conditions
Where it's being run
103 sites across 68 statesStudy leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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What this trial measures
- Part 1 and 2: Proportion of patients achieving Complete Renal Response (CRR) at week 24 in the absence of renal flaresBaseline and week 24
Part 1: To evaluate the proportion of patients achieving complete renal response with iptacopan treatment "A" plus standard of care, compared to treatment alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "B" plus standard of care, compared to treatment "D" alone Part 2: To evaluate the proportion of patients achieving complete renal response with Iptacopan treatment "C" plus standard of care, compared to treatment "D" alone Complete Renal Response is defined as meeting the following criteria: estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2 or no less than 85% of baseline value, and 24h urine protein-to-creatinine ratio (UPCR) ≤ 0.5 g/g.