Status:
COMPLETED
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
Lead Sponsor:
Prim. Priv. Doz. Dr. Daniel Cejka
Collaborating Sponsors:
Amgen
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 phase...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03795558
Start Date
May 1 2019
End Date
March 1 2022
Last Update
March 23 2022
Active Locations (1)
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1
Ordensklinikum Linz GmbH Elisabethinen
Linz, Upper Austria, Austria, 4020