A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of Allograft-threatening BK Virus Infection in Kidney Transplant Recipients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Incidence of BK viremia
研究概览
简要总结
This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.
详细描述
This is a non-confirmatory, randomized, placebo-controlled, blinded, proof-of-concept study in kidney transplant recipients. Approximately 96 eligible subjects are planned to be randomized 2:1 to receive MAU868 or placebo. At least 78 subjects are expected to complete the study. The study will consist of a pre-treatment (screening) consenting period, a 24 week treatment period (consisting of 6 monthly i.v. doses of MAU868 or placebo) and a 24 week follow-up period. Subjects who complete the study per protocol will attend a total of 16 visits over a period of 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This is a patient, investigator and sponsor-blinded study. Patients and investigators will remain blinded to study treatment throughout the study,
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female recipients of a first or second kidney or kidney-pancreas transplant who weigh at least 30 kg and are at least 7 years of age (in the US, 18 years of age or above) at the time of transplantation.
- •Recipients of organs from a heart-beating deceased, non-heart-beating deceased, living unrelated, or human leukocyte antigen (HLA)-mismatched living related donor.
- •Recipients who are treated with lymphocyte-depleting induction therapy (e.g., rabbit antithymocyte globulin, alemtuzumab). Subjects treated with rabbit antithymocyte globulin must receive a total dose of at least 3 mg/kg. Subjects treated with alemtuzumab must receive a total dose of at least 20 mg.
- •Recipients of a kidney with a cold ischemia time (CIT) <36 hours.
排除标准
- •Recipients of organs from identical twins or living, HLA-matched, related donors.
- •ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant (isolated positive B cell crossmatches are not an exclusion criterion).
- •Recipients who are treated with non-lymphocyte-depleting induction therapy (e.g., basiliximab) or no induction therapy.
- •Recipients who are treated or planned to be treated with mTOR inhibitors as part of their initial immunosuppression regimen post-transplantation.
- •Recipients who require antibody-depletion prior to transplantation and in the opinion of the investigator are likely to require antibody-depletion after transplantation. Antibody-depleting therapies include but are not necessarily limited to plasmapharesis, immunoadsorption, and IVIg.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by hCG testing.
- •Current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (TB) or any history, in the opinion of the investigator, that confers a risk of reactivation of TB and precludes the use of conventional immunosuppression.
- •History of splenectomy or asplenia.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug.
研究组 & 干预措施
Placebo
Matching placebo
干预措施: Placebo (Biological)
MAU868
BKV-specific, pan-serotype neutralizing antibody
干预措施: MAU868 (Biological)
结局指标
主要结局
Incidence of BK viremia
时间窗: 24 weeks
\>1000 copies/mL through 24 weeks
次要结局
- Immunogenicity of MAU868(48 weeks)
- Pharmacokinetics of MAU868(48 weeks)