Clinical trial NCT03795558: A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
Official title: A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: Elisabethinen Hospital
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2019-01-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This is a single-center, prospective, dose-escalation, pilot study. Starting dose 2.5 mg thrice weekly dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.
Primary purpose: DIAGNOSTIC

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

Detailed description: 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.

For the individual patient, the study duration will be 9 months

Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
measure: T50-Laboratory Test for measuring calcification
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Upper Austria
Study officials:
affiliation: Head of Nephrology
name: Daniel Cejka, Md
role: PRINCIPAL_INVESTIGATOR
References: