NCT01442337终止2 期
A Phase 2/3, Double-Blind, Placebo-Controlled, Two-Part Study (Part 1 Open-Label) to Assess the Safety, Efficacy and Pharmacokinetics of Single Intravenous Doses of ASP8597 (Diannexin) in de Novo Kidney Transplant Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 19
- 主要终点
- Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and tolerability of a single intravenous dose of ASP8597 in kidney transplant recipients.
详细描述
This is a two-part study. Part 1 (Phase 2) has completed enrollment. Subjects are currently being followed per protocol. Data from Part 1 will be used to determine the doses used in Part 2 (Phase 3). Part 2 will enroll approximately 573 subjects and is planned to have 2 doses of ASP8597 (low dose and either the high or highest dose) along with placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is scheduled to receive a kidney transplant from a deceased donor meeting at least one of the following criteria:
- •Expanded Criteria Donor (ECD)
- •i Donor was > 60 years of age, OR
- •ii. Donor was 50-59 years of age, inclusive, and met at least two of the following criteria:
- •Donor died of a cerebral bleed
- •Donor had a history of hypertension
- •Donor's terminal serum creatinine concentration was > 1.5 mg/dL
- •Donation after Cardiac Death (DCD) - Donor was pronounced dead prior to procurement of the kidney
- •Standard Criteria Donor (SCD)
- •i. Donor with terminal serum creatinine < 1.5 mg/dL where kidney is anticipated to have a minimum of 24 hours of cold ischemia prior to transplantation, OR
- •ii. Donor with terminal serum creatinine > 1.5 mg/dL and any cold ischemic time up to exclusion limit
- •Female subject is not pregnant and agrees to use an acceptable form of contraception throughout study
- •Male subject agrees to use an adequate method of contraception and agrees to no sperm donation throughout the study
排除标准
- •Female subject is pregnant or lactating
- •Donor kidney is anticipated to have more than 40 hours of cold ischemia time
- •Donor is > 66 years of age
- •Donor meets both DCD and ECD criteria
- •Subject has previously received, or is receiving an organ transplant other than a kidney
- •Subject has a positive T or B cell crossmatch by the investigational site's standard method of determination. For recipients where only a flow cytometry crossmatch is performed and is positive in either T or B cell testing, recipients are excluded only if donor specific, anti-HLA antibody is detected by flow cytometry based, specific anti-HLA antibody testing
- •Subject has ABO blood type incompatibility with his/her organ donor
- •Recipient or donor is known by medical history to be seropositive for human immunodeficiency virus (HIV)
- •Subject has a known bleeding diathesis
- •Subject has a International Normalized Ratio (INR) > 1.5 times upper limit of normal at Screening
- •Subject has a platelet count < 100,000 platelets/µL at Screening
- •Subject used anti-platelet agents [e.g., Plavix® (clopidogrel bisulfate), Brilinta® (ticagrelor)] (with the exception of aspirin < 100 mg/day for cardiovascular prophylaxis), anti-coagulants [e.g., Pradaxa® (dabigatran), Xarelto® (rivaroxaban)], anti-thrombotics, and/or blood-thinning agents within the 10 days prior to Screening; and/or subject is expected to require use of any of these agents during the first 15 days of the study period (with the exception of standard of care peri-operative administration of heparin for DVT prophylaxis)
- •Subject has an uncontrolled concomitant infection
- •Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- •Subject currently is participating in an investigational drug study, or participated in an investigational drug study within the last 30 days)
- •Subject has a history of or is believed to have used an illicit drug(s) and/or abused alcohol within the last 3 months
- •Subject has an unstable psychiatric illness
- •Subject has previously received ASP8597 or participated in a study involving ASP8597
研究组 & 干预措施
ASP8597 low dose
Experimental
干预措施: ASP8597 (Drug)
ASP8597 high dose
Experimental
干预措施: ASP8597 (Drug)
ASP8597 highest dose
Experimental
干预措施: ASP8597 (Drug)
Placebo
Placebo Comparator
Placebo comparator used in Part 2 only
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
时间窗: 3 days
Part 1 PK variable
Pharmacokinetic variable for ASP8597: Area under the concentration-time curve from time 0 to infinity (AUCinf)
时间窗: 3 days
Part 1 PK variable
Pharmacokinetic (PK) variable for ASP8597: Maximum concentration (Cmax)
时间窗: 3 days
Part 1 PK variable
Estimated glomerular filtration rate (eGFR) using abbreviated Modified Diet in Renal Disease (MDRD) formula - Part 2
时间窗: 12 months
Part 2 efficacy variable
次要结局
- Pharmacokinetic variable for ASP8597: Time to attain Cmax (Tmax)(3 days)
- Pharmacokinetic variable for ASP8597: Clearance (CL)(3 days)
- Pharmacokinetic variable for ASP8597: Volume of Distribution (Vz)(3 days)
- Pharmacokinetic variable for ASP8597: Apparent terminal elimination half-life (t1/2)(3 days)
- Requirement of dialysis within the first 7 days post transplant - Part 1(7 days)
- eGFR using abbreviated MDRD formula - Part 1(12 months)
- Requirement of dialysis within the first 7 days post transplant - Part 2(7 days)
- Patient survival(12 months)
- Graft survival(12 months)
- Biopsy-proven acute rejection (BPAR)(12 Months)
- Clinically treated rejection(12 months)
研究者
研究点 (19)
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