EUCTR2018-000421-31-AT进行中（未招募）1 期
A study to investigate the influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients - Etelcalcetide-T50-CKD5D
Ordensklinikum Linz GmbH, ELISABETHINEN, Interne 30 个研究点目标入组 20 人开始时间: 2018年10月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adults = 18 years old
- •Prevalent patients (= 3 months on dialysis) treated with thrice weekly hemodialysis (HD) or hemodiafiltration (HDF)
- •Secondary hyperparathyroidism defined as PTH levels > 9x ULN according to current KDIGO guidelines if therapy-naïve, or patients already treated with calcium receptor sensitizers with PTH > 2x ULN
- •Calcium concentrations of dialysate stable for at least 2 weeks prior to screening
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Currently receiving treatment in another investigational device or drug study or participation in non-interventional studies
- •Current treatment with etelcalcetide (Parsabiv©) or treatment with etelcalcetide within 3 months prior to study inclusion
- •Patient has known sensitivity to any of the products or components of Parsabiv©
- •Patient has received a parathyroidectomy
- •Parathyroidectomy planned or expected during the study period
- •Elective kidney transplant scheduled during the study period
- •Therapy with bisphosphonates within the past 12 months
- •Therapy with denosumab within the past 6 months
- •Antacids containing aluminum, calcium, magnesium or bicarbonate
- •Patient has a history of a QTc interval >480ms or ventricular arrhythmias or Torsades de Pointes
- •Patient has a history of myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
- •Pregnant or nursing (lactating) women
- •PTH Levels <9x ULN at the dialysis session immediately precedning the Initiation of etelcalcetide Treatment
- •Albumin-corrected Serum calcium <2,08 mmol/l at the dialysis session immediately preceding the Initiation of etelcalcetide treatment
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