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

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka
• Collaborator: Amgen

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