Safety and Dialysability of Dotarem® in Dialysed Patients - Phase 1 Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Dialysability of Dotarem® in Dialysed Patients
研究概览
简要总结
To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
详细描述
Ten adult patients suffering from end stage renal failure and requiring hemodialysis treatment for 3 times were enrolled. Patients received a single dose of Dotarem® at 0.1 mmol/kg before being submitted to hemodialysis to assess the dialysability of Dotarem® . After injection of Dotarem®, 3 sessions of hemodialysis were performed as follows:
The first hemodialysis session started between 1 to 2 h after the injection; The second hemodialysis session occurred 2 days (i.e., 48 ± 2 h) after the Dotarem® injection; The third hemodialysis session occurred 4 days (i.e., 96 ± 4 h) after the Dotarem® injection.
The decrease in serum Dotarem® concentration was assessed after each hemodialysis session. Safety assessments included adverse events (AEs), vital signs, injection-site tolerance, and laboratory assessments.Two safety follow-up visits were performed: one 3 weeks (± 2 days) and one 3 months (± 4 days) after the Dotarem® injection.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18 years
- •Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)
- •Female Subjects with effective contraception (contraceptive pill or Intra-Uterine Device), or surgically sterilized or post-menopausal (minimum 12 months amenorrhea)
- •Subjects having provided their written informed consent to participate in the trial
排除标准
- •Known allergy to gadolinium chelates
- •Pregnant, breast feeding, or planning to become pregnant during the trial
- •Having received or scheduled to be injected with any contrast agent within 7 days before or after the Dotarem® injection
- •Schedule to receive erythropoietin (EPO) or iron therapy during 1 week after the Dotarem® injection
- •Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- •Evidence of hepatitis C and/or positive hepatitis C antibody and/or positive hepatitis B surface antigen
- •History of hypersensitivity to drugs with a similar chemical structure
研究组 & 干预措施
Dotarem®-injected patients
Male or female subjects, aged ≥18 years,suffering from end-stage renal failure and requiring hemodialysis treatment 3 times per week, were submitted to a single Dotarem® IV injection at 0.1 mmol/kg before being submitted to 3 hemodialysis sessions to assess the decrease of Dotarem® concentration in the blood.
干预措施: Dotarem® IV injection at 0.1 mmol/kg (Drug)
结局指标
主要结局
Dialysability of Dotarem® in Dialysed Patients
时间窗: Dotarem® dialysability assessed up to 4 days after Dotarem® administration
To evaluate the decrease in seric concentration of gadolinium, after each hemodialysis session of patients injected with 0.1 mmol/kg of Dotarem® . The percent change of gadolinium concentration is calculated by estimating the amount of serum gadolinium before and after each hemodialysis session. Calculations are performed only for subjects with concentration above the lower limit of quantification (LLQ)
次要结局
- Safety of Dotarem® in Dialysed Patients Evaluated by the Number of Patients Experiencing Adverse Events.(Safety assessed from patients inclusion until the last follow-up visit 3 months after Dotarem® administration)