NCT04335578终止1 期
A Multicenter, Randomized, Placebo-Controlled Investigator-Blind, Participant-Blind Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 5
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is an Investigator-blind and participant-blind study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Functioning living or deceased donor allograft >=1 year post-transplantation
- •Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (>=25% IF/TA)
- •Progressive loss in kidney function observed after the first year post-transplant, defined as an estimated glomerular filtration rate (eGFR) decline of ≥3 mL/min/year for at least 24 months prior to screening, with a minimum of 2 documented measurements per year (minimum of 4 documented measurements in the 24-month period, performed at least 1 month apart)
- •An eGFR >=30 mL/min/1.73 m^2 for a period of 6 months up to screening
- •Stable standard of care concomitant medication for 3 months prior to screening
- •Participant is male or female, >=18 years of age
排除标准
- •Recipient of multi-organ transplant (with the exception of repeated kidney transplant recipients, and/or corneal transplant recipients)
- •Screening biopsy shows evidence of significant active antibody-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the Principal Investigator (PI)
- •Screening biopsy shows evidence of T cell-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the PI
- •Screening biopsy shows evidence of de novo or recurrent glomerular disease that may affect the conduct of the study (eg, require change in treatment) according to the PI
- •Proteinuria ≥1500 mg/g at screening
- •Participant who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening
- •Participant has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of investigational medicinal product (IMP)
- •Participant has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer or history of delayed wound healing
- •Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening
研究组 & 干预措施
Zampilimab Cohorts
Experimental
Participants will be randomized to receive zampilimab (UCB7858).
干预措施: Zampilimab (Drug)
Placebo
Placebo Comparator
Participants randomized to this arm will receive matching Placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the administration of investigational medicinal product (IMP) or any unresolved event already present before administration of IMP that worsens in intensity following exposure to the treatment.
次要结局
- Serum concentration of zampilimab(From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680))
- Urine concentration of zampilimab(From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680))
研究者
研究点 (5)
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