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

March 22, 2022 updated by: Prim. Priv. Doz. Dr. Daniel Cejka
This is a single-center, prospective, dose-escalation, pilot study in 15 end-stage renal disease patients on chronic hemodialysis with secondary hyperparathyroidism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Upper Austria
      • Linz, Upper Austria, Austria, 4020
        • Ordensklinikum Linz Gmbh Elisabethinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Etelcalcetide 2.5 mg
Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
Drug: Etelcalcetide
Up-Titration
Other Names:
  • Parsabiv
EXPERIMENTAL: Etelcalcetide 5 mg
Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
Drug: Etelcalcetide
Up-Titration
Other Names:
  • Parsabiv
EXPERIMENTAL: Etelcalcetide 7,5 mg
Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
Drug: Etelcalcetide
Up-Titration
Other Names:
  • Parsabiv
EXPERIMENTAL: Etelcalcetide 10 mg
Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
Drug: Etelcalcetide
Up-Titration
Other Names:
  • Parsabiv
EXPERIMENTAL: Etelcalcetide 12,5 mg
Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
Drug: Etelcalcetide
Up-Titration
Other Names:
  • Parsabiv
EXPERIMENTAL: Etelcalcetide 15 mg
Etelcalcetide, starting dose of 2.5mg thrice weekly, dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly
Drug: Etelcalcetide
Up-Titration
Other Names:
  • Parsabiv

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T50-Laboratory Test for measuring calcification
Time Frame: 32 weeks
The changes in T50 values between the different study phases will be evaluated as the primary outcome.
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prim. Priv. Doz. Dr. Daniel Cejka

Collaborators

Amgen

Investigators

  • Principal Investigator: Daniel Cejka, MD, Head of Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ACTUAL)

December 21, 2021

Study Completion (ACTUAL)

March 1, 2022

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (ACTUAL)

January 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Etelcalcetide-T50-CKD5D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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