Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT03795558
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2018-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
Sponsor:
Prim. Priv. Doz. Dr. Daniel Cejka
Organization:
Study Overview
Official Title:
A Study to Investigate the Influence of PTH-lowering by Etelcalcetide (Parsabiv®) on the Calcification Propensity of Serum in Dialysis Patients
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: