Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- renal remission
研究概览
简要总结
Meta-analyses in adults suggest equivalence of clinical efficacy of intravenous cyclophosphamide and mycophenolate mofetil when dosed based on patient weight or body-surface-area (MMFBSA), as is the current standard for the treatment of proliferative lupus nephritis (LN) treatments in the U.S. Pharmacokinetically-guided precision dosing of MMF (MMFPK) may offer a beneficial modification of the current standard treatment in that MMKPK promises over 30% higher LN response rates than MMFBSA. The objective of the proposed randomized, controlled study is to compare the efficacy and safety of pharmacokinetically-guided precision dosing of MMF (MMFPK) with conventional dosing regimens of MMF (MMFBSA) among children with proliferative LN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New diagnosis with proliferative LN based on kidney biopsy done within 4 weeks of enrollment Diagnosis with childhood-onset SLE (cSLE) as per the ACR criteria95, 96 Age 8 - 17 years at the time of enrollment96 Tolerates oral MMF
排除标准
- •Perceived or stated inability to adhere to study protocol, Lack of use of highly effective birth control method. Presence of cSLE features that a-priori suggest that the patient benefits from other therapy than that suggested by the study protocol, History of significant kidney disease prior to the diagnosis with cSLE, Need for renal replacement therapy at the time of enrolment, Concurrent therapy with CYC or rituximab.
研究组 & 干预措施
MMF PK
干预措施: Mycophenolate Mofetil (Drug)
MMF BSA
干预措施: Mycophenolate Mofetil (Drug)
结局指标
主要结局
renal remission
时间窗: 26 week
defined as at least PRR (CRR or PRR)
次要结局
- Complete Renal Remission(week 26)
研究者
Hermine Brunner, MD
Director, Division of Rheumatology
Children's Hospital Medical Center, Cincinnati