A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 9
- 主要终点
- Safety Incidences
研究概览
简要总结
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
详细描述
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.
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
盲法说明
None ( Open Label)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥ 18 years of age
- •Recipient of their first kidney transplant from a living or deceased donor
- •Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
排除标准
- •Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
- •Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;
- •Previous treatment with AT 1501 or any other anti CD40LG therapy
- •The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant
- •Will receive a kidney with an anticipated cold ischemia time of > 30 hours;
- •Will receive a kidney from a donor that meets any of the following criteria:
- •Donation after Cardiac Death (DCD) criteria; or
- •Extended Criteria Donor (ECD) criteria, defined as:
- •Is blood group (ABO) incompatible; or
- •Age ≥ 60 years; or Age 50-59 years with any 2 of the following criteria:
- •Death due to cerebrovascular accident
- •History of hypertension
- •Terminal creatinine ≥ 133 μmol/L (1.5 mg/dL)
- •Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
- •Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
- •History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:
- •Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
研究组 & 干预措施
AT-1501 Single Arm
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
干预措施: AT-1501 (Drug)
结局指标
主要结局
Safety Incidences
时间窗: Through study completion, an average up to 20 months
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
Pharmacokinetic- PK profile
时间窗: Day 1 and at steady state Month 3
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Pharmacokinetic- Tmax
时间窗: Day 1 and at steady state Month 3
Time to reach maximum observed plasma concentration (Tmax)
Pharmacokinetic- Ke
时间窗: Day 1 and at steady state Month 3
Terminal elimination rate constant (Ke)
Pharmacokinetic- Cmax
时间窗: Day 1 and at steady state Month 3
Maximum observed plasma concentration (Cmax)
Pharmacokinetic- Area under the plasma concentration
时间窗: Day 1 and at steady state Month 3
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Pharmacokinetic- (t1/2)
时间窗: Day 1 and at steady state Month 3
Terminal phase half-life (t1/2)
Pharmacokinetic- CL
时间窗: Day 1 and at steady state Month 3
Clearance (CL)
Pharmacokinetic- (Vdss)
时间窗: Day 1 and at steady state Month 3
Volume of distribution at steady state (Vdss)
次要结局
未报告次要终点