End stage renal disease
Conditions
Interventions
Trade Name: Parsabiv®
Product Name: Parsabiv
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ETELCALCETIDE
CAS Number: 8000019-76-3
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Ordensklinikum Linz GmbH, ELISABETHINEN, Interne 3
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this pilot study is to investigate the effect of PTH-lowering using etelcalcetide on the overall propensity of serum for calcification utilizing the novel T50-test in prevalent end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism. ;Secondary Objective: The Change of PTH values;Primary end point(s): The Primary endpoint is the Change in T50 value;Timepoint(s) of evaluation of this end point: every visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change of mean PTH levels;Timepoint(s) of evaluation of this end point: every studyvisit | — |
Countries
Austria
Contacts
Public ContactClinical Trial Administration
Ordensklinikum Linz GmbH, ELISABETHINEN
Outcome results
None listed