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

NCT03795558 | Completed Phase 2

• 1 other identifier: Etelcalcetide-T50-CKD5D
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• T50-Laboratory Test for measuring calcification

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

  32 weeks

Study Arms (6)

Etelcalcetide 2.5 mg

EXPERIMENTAL

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

Etelcalcetide 5 mg

EXPERIMENTAL

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

Etelcalcetide 7,5 mg

EXPERIMENTAL

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

Etelcalcetide 10 mg

EXPERIMENTAL

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

Etelcalcetide 12,5 mg

EXPERIMENTAL

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

Etelcalcetide 15 mg

EXPERIMENTAL

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

Interventions

Etelcalcetide DRUG

Up-Titration

Also known as: Parsabiv

Etelcalcetide 10 mg; Etelcalcetide 12,5 mg; Etelcalcetide 15 mg; Etelcalcetide 2.5 mg; Etelcalcetide 5 mg; Etelcalcetide 7,5 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently receiving treatment in another investigational device or drug study or participation in non-interventional studies
• 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

Sponsors & Collaborators

• Prim. Priv. Doz. Dr. Daniel Cejka: lead
• Amgen: collaborator

Study Sites (1)

Ordensklinikum Linz GmbH Elisabethinen

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

etelcalcetide hydrochloride

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Cejka, Md

  Head of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Nephrology department

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: January 7, 2019
• Study Start: May 1, 2019
• Primary Completion: December 21, 2021
• Study Completion: March 1, 2022
• Last Updated: March 23, 2022

Record last verified: 2022-03

Locations

AU (1)