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

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

Etelcalcetide

About this trial

This is an interventional diagnostic trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ordensklinikum Linz GmbH Elisabethinen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Etelcalcetide 2.5 mg

Etelcalcetide 5 mg

Etelcalcetide 7,5 mg

Etelcalcetide 10 mg

Etelcalcetide 12,5 mg

Etelcalcetide 15 mg

Arm Description

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

Outcomes

Primary Outcome Measures

T50-Laboratory Test for measuring calcification

The changes in T50 values between the different study phases will be evaluated as the primary outcome.

Secondary Outcome Measures

Full Information

NCT ID

NCT03795558

First Posted

September 18, 2018

Last Updated

March 22, 2022

Sponsor

Prim. Priv. Doz. Dr. Daniel Cejka

Collaborators

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT03795558

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

December 21, 2021 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prim. Priv. Doz. Dr. Daniel Cejka

Collaborators

Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Sequential Assignment

Model Description

This is a single-center, prospective, dose-escalation, pilot study. Starting dose 2.5 mg thrice weekly dose will be escalated every 4 weeks in 2.5mg/dialysis session increments to a maximum dose of 15mg thrice weekly.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Etelcalcetide 2.5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Etelcalcetide 5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Etelcalcetide 7,5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Etelcalcetide 10 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Etelcalcetide 12,5 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Etelcalcetide 15 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Etelcalcetide

Other Intervention Name(s)

Parsabiv

Intervention Description

Up-Titration

Primary Outcome Measure Information:

Title

T50-Laboratory Test for measuring calcification

Description

The changes in T50 values between the different study phases will be evaluated as the primary outcome.

Time Frame

32 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Cejka, Md

Organizational Affiliation

Head of Nephrology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ordensklinikum Linz GmbH Elisabethinen

City

Linz

State/Province

Upper Austria

ZIP/Postal Code

4020

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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