NCT03795558

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Prim. Priv. Doz. Dr. Daniel Cejka · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Up-Titration

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-12-21
• Completion: 2022-03-01
• First posted: 2019-01-07
• Last updated: 2022-03-23

Locations

1 site across 1 country: Austria