A Phase 1, Single Site, Open-Label Study to Assess the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- • To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis
研究概览
简要总结
This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase administered to hemodialysis patients.
A single dose of pegloticase will be administered intravenously to male or female hemodialysis patients (N = 12) starting 3 hour prior to dialysis.
The study consists of a Screening Period, a Treatment Period, and Follow up Period.
详细描述
End stage renal disease (ESRD) patients that require hemodialysis typically undergo hemodialysis treatment 3 times per week. As such, medications can be dialyzed off, reducing their clinical effectiveness; this study is being conducted to understand how dialysis affects the pharmacokinetics (PK) and pharmacodynamics (PD) of pegloticase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 and 75 years of age, inclusive
- •Agrees to employ best possible methods to abstain from becoming pregnant or impregnating another.
- •Stage V chronic kidney patients with minimal or no residual renal function receiving hemodialysis and stable on hemodialysis (3x week)
- •BMI = 18.5 kg/m2 to < 45 kg/m2
排除标准
- •Any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion, or any other condition that may place the subject at risk
- •Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Uncontrolled congestive heart failure
- •Refractory chronic gout
- •History of drug and/or alcohol abuse within 6 months prior to screening
- •History of or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
- •Donation of blood or plasma within 30 days prior to dosing
- •History of or current hepatitis, or carriers of hepatitis B surface antigen (HbsAg) and/or hepatitis C antibodies (anti-HC).
- •Use of an investigational drug or product, within 30 days
- •History of clinically significant drug allergies or sensitivities
- •Females with a positive pregnancy test or who are breast feeding at Screening or plan to breast feed within 30 days of dosing
- •A baseline QTc interval ≥ 490 milliseconds for males and ≥ 510 milliseconds for females
- •Is unable to refrain from alcohol
- •Has taken any prescription or over the counter medication within 7 days prior to treatment day that, in the opinion of the Investigator, could be expected to confound the PK or metabolism of the study drug
- •Has taken the following herbal agents or nutraceuticals within 7 days prior to Screening: chapparal, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's Wort, or valerian
- •Has poorly controlled malignant hypertension (systolic blood pressure [SBP] > 200 mm Hg and/or diastolic blood pressure [DBP] > 120 mm Hg,
- •Concurrent use of urate-lowering drugs
研究组 & 干预措施
Pegloticase
Pegloticase 8 mg single intraveneous dose
干预措施: Pegloticase (Drug)
结局指标
主要结局
• To evaluate the pharmacokinetics (PK) of pegloticase after a single-dose administration to hemodialysis patients when administered starting 3 hours before dialysis
时间窗: 1 month
次要结局
- • To evaluate the pharmacodynamics (PD) of pegloticase and SUA, before and after hemodialysis sessions(1 month)