A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients

Prim. Priv. Doz. Dr. Daniel Cejka1 个研究点分布在 1 个国家目标入组 37 人开始时间: 2019年5月1日最近更新: 2022年3月23日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 37
试验地点: 1
主要终点: T50-Laboratory Test for measuring calcification

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.

详细描述

Fifteen prevalent and stable hemodialysis patients with secondary hyperparathyroidism eligible for treatment with calcium receptor sensitizers according to current KDIGO will be included.

Study phases will begin and end on the day of the first hemodialysis session of the week.

The run-in phase will last 4 weeks. No calcimimetics will be prescribed during the run-in phase.

The treatment phase starts with a dose of etelcalcetide is 2.5mg thrice weekly. Etelcalcetide dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.

The wash-out Phase starts after completion of the 15mg thrice-weekly phase or in case a pre-specified safety endpoint is reached, etelcalcetide will be discontinued and patients will be followed for additional 8 weeks to study any potential reversibility of PTH lowering on T50 results.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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
•Albumin corrected calcium ≥ 2,08 mmol/l
•Calcium concentrations of dialysate stable for at least 2 weeks prior to screening

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 symptomatic 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