EUCTR2019-004154-28-ES进行中（未招募）1 期
A Phase 1b/2 study to evaluate the safety, pharmacokinetics, and preliminary efficacy of isatuximab (SAR650984) in patients awaiting kidney transplantation
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Participant must be 18 to 70 years of age
- •- Diagnosis of chronic kidney disease (CKD) and active candidate on the kidney donor waitlist at the time of screening.
- •- Body mass index (BMI) =40 kg/m2.
- •- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •- Capable of giving signed informed consent.
- •For Participants in Cohort A: active candidates on the kidney waitlist with living donor.
- •For participants in Cohort B: active candidates on the kidney waitlist with no living donor cleared for donation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •- Significant cardiac dysfunction
- •- Known active, recurrent, or chronic infection
- •- Active lupus or uncontrolled diabetes
- •- Prior treatment with rituximab within 6 months from SAR650984 administration
- •- Inadequate organ and bone marrow function at screening
- •- Pregnant or breastfeeding women or women who intend to become pregnant during participation in the study
- •- Known intolerance or hypersensitivity to any component of SAR650984 or premedications
- •- Participants who are not suitable for participation as judged by the Investigator
研究者
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