JPRN-jRCT2080223765已完成3 期
A randomized, Controlled Double-blind study Comparing the Efficacy and Safety of Voclosporin (23.7 mg Twice Daily) with Placebo in Achieving Renal response in Subjects with Active Lupus Nephritis
Aurinia Pharmaceuticals Inc./ CMIC Co., Ltd.0 个研究点目标入组 357 人开始时间: 2018年1月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 357
研究概览
简要总结
Treatment with voclosporin resulted in a clinically meaningful and statistically significant higher renal response rate compared to placebo when given with MMF and steroids; the odds of achieving renal response were greater for voclosporin versus placebo (OR 2.65; 95% CI: 1.64, 4.27; p<0.001). Treatment benefit of voclosporin was seen in all pre-specified subgroups.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria
- •Subjects with evidence of active nephritis, defined as follows:
- •Kidney biopsy result within 2 years prior to screening indicating Class III, IV S, IV-G (alone or in combination with Class V), or Class V LN with a doubling or greater increase of urine protein creatinine ratio (UPCR) within the last 6 months to a minimum of >=1.5 mg/mg for Class III/IV or to a minimum of >=2 mg/mg for Class V at screening. Biopsy results over 6 months prior to screening must be reviewed with a medical monitor to confirm eligibility.
- •Kidney biopsy result within 6 months prior to screening indicating Class III, IV S, or IV-G (alone or in combination with Class V) LN with a UPCR of >=1.5 mg/mg at screening.
- •Kidney biopsy result within 6 months prior to screening indicating Class V LN and a UPCR of >=2 mg/mg at screening.
- •A biopsy can be performed during screening, if not available. The above criteria must be fulfilled at baseline.
排除标准
- •Estimated glomerular filtration rate (eGFR) of =<45 mL/minute at screening.
- •Current or medical history of:
- •-Congenital or acquired immunodeficiency.
- •-In the opinion of the investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.
- •-Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision.
- •-Lymphoproliferative disease or previous total lymphoid irradiation.
- •-Severe viral infection or known HIV infection.
- •-Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.
- •Other known clinically significant active medical conditions, such as:
- •-Severe cardiovascular disease, liver dysfunction or chronic obstructive pulmonary disease or asthma requiring oral steroids or any other overlapping autoimmune condition for which the condition or the treatment of the condition may affect the study assessments or outcomes.
研究者
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