NCT07611214招募中4 期
PRESERVE: A Multi-Center Phase 4 Study of the Efficacy and Safety of LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab at Inducing Rapid Renal Response in Patients With Lupus Nephritis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 27
研究概览
简要总结
The goal of this clinical study is to assess the efficacy and safety of LUPKYNIS® in combination with belimumab, obinutuzumab or anifrolumab at inducing rapid renal response in patients with lupus nephritis (LN).
详细描述
Patients with LN will be administered LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab. Additionally, patients will receive treatment with a mycophenolic acid analog (MPAA), specifically mycophenolate mofetil (MMF) or mycophenolic acid (MPA), and oral prednisone (or equivalent).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-75 years old
- •Diagnosed with biopsy-proven lupus nephritis (LN) according to the 2003 International Society of Nephrology (ISN) / Renal Pathology Society (RPS) (class III, class IV, class III/V or class IV/V)
- •Urine protein-to-creatine ratio (UPCR) ≥0.5 g/g and <5.0 g/g from a first morning void (FMV) urine sample
- •Estimated glomerular filtration rate (eGFR) of ≥45 mL/min/1.73 m2
- •Concomitant biologic:
- •Patients on the belimumab or anifrolumab treatment regimens are receiving belimumab or anifrolumab (as applicable) prior to Screening or will initiate belimumab or anifrolumab (as applicable) on or before Day
- •Patients on the obinutuzumab treatment regimen must have received at least 2 administrations of obinutuzumab prior to Screening.
- •Willing to take mycophenolic acid analog (MPAA), either by continuing current MPAA therapy or by initiating it on or before Day 1
- •Willing to take corticosteroids, either by continuing current corticosteroids (prednisone [or equivalent]) or by initiating on or before Day 1
排除标准
- •Any B cell targeted therapy except for the concomitant biologics (belimumab and obinutuzumab) within 1 year prior to Screening unless demonstration of B cell count within the normal range
- •Cyclophosphamide or any calcineurin inhibitor other than voclosporin (eg, cyclosporine and tacrolimus) within 3 months prior to Screening
- •Any other immunosuppressive therapy except for the concomitant drugs (anifrolumab, MPAAs and oral prednisone [or equivalent]) and immunosuppressive agents used to treat a patient's underlying systemic lupus erythematosus (SLE), including, but not limited to, the examples below, within 30 days or 5 half-lives, whichever is longer, prior to Screening:
- •Anti-tumor necrosis factor (TNF) therapy (eg, adalimumab, etanercept, infliximab)
- •Anti-interleukin therapy (eg, risankizumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tocilizumab, dupilumab)
- •T cell costimulation modulator (eg, abatacept)
- •Intravenous immunoglobulin (IVIg)
- •Janus kinase (JAK) inhibitors (eg, upadacitinib)
- •Pregnant, breastfeeding or intending to become pregnant during the Study
研究组 & 干预措施
LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
Experimental
Patients will also receive concomitant mycophenolic acid analog and corticosteroids.
干预措施: mycophenolic acid analog (MPAA) (Drug)
LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
Experimental
Patients will also receive concomitant mycophenolic acid analog and corticosteroids.
干预措施: corticosteroid (Drug)
LUPKYNIS in combination with belimumab, obinutuzumab or anifrolumab
Experimental
Patients will also receive concomitant mycophenolic acid analog and corticosteroids.
干预措施: belimumab, obinutuzumab or anifrolumab (Biological)
研究者
研究点 (27)
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