A study to investigate the influence of lowering PTH values in blood using medication called Etelcalcetide (Parsabiv®) on Calcification Preopensity of the blood in Patients with dialysis therapy.

Phase 1

• Conditions: End stage renal disease; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2018-000421-31-AT
• Lead Sponsor: Ordensklinikum Linz GmbH, ELISABETHINEN, Interne 3

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-09
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified