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Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

A Multicenter, Multiple-dose, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet Hydrochloride With Intravenous Doses of Etelcalcetide (AMG 416) in Asian Hemodialysis Subjects With Secondary Hyperparathyroidism

NCT03299244•Amgen

View on ClinicalTrials.gov

Summary

The primary objective is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum intact parathyroid hormone (PTH) levels by \> 30% from baseline among participants with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has provided informed consent prior to performing any study-related activities/procedures.
•Male or female subjects ≥ 18 years of age or older at the time of signing informed consent.
•Subject must be receiving maintenance hemodialysis 3 times weekly for at least 3 months, with adequate hemodialysis based on a delivered measure of dialysis adequacy (Kt/V) ≥ 1.2 or urea reduction ratio ≥ 65% within 4 weeks prior to screening laboratory assessments. The Kt/V formula used for a subject must be the formula used during routine care prior to screening.
•Dialysate calcium concentration must be ≥ 2.5 mEq/L (1.25 mmol/L) and stable for at least 4 weeks prior to screening laboratory assessments, and must remain ≥ 2.5 mEq/L (1.25 mmol/L) for the duration of the study.
•Subject must have SHPT as defined by one central laboratory screening predialysis serum PTH value \> 500 pg/mL, within 2 weeks prior to randomization.
•Subject currently receiving vitamin D sterols must have had no more than a maximum dose change of 50% within the 4 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable doses for the duration of the study, except for adjustments allowed per protocol or for safety reasons.
•Subject must have 1 screening predialysis serum cCa laboratory value ≥ 8.3 mg/dL measured within 2 weeks prior to randomization.
•A subject receiving calcium supplements must have had no more than a maximum dose change of 50% within 2 weeks prior to screening laboratory assessments and remain stable through randomization.
•A subject receiving phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening laboratory assessments, remain stable through randomization, and be expected to maintain stable dose for the duration of the study, except for adjustments allowed per protocol or for safety reasons.

Exclusion Criteria

•Currently receiving treatment in another investigational device or drug study, or ≤ 30 days since ending treatment on another investigational device or drug study(s). Other investigational procedures while participating in this study are excluded.
•Subject has received etelcalcetide in a prior clinical trial of etelcalcetide.
•Subject has received cinacalcet during the 3 months prior to the first screening laboratory assessments.
•Subject has known sensitivity to any of the products or components of either cinacalcet or etelcalcetide to be administered during dosing.
•Subject has previously been randomized in this study.
•Anticipated or scheduled parathyroidectomy during the study period.
•Subject has received a parathyroidectomy within 6 months prior to dosing.
•Anticipated or scheduled kidney transplant during the study period.
•Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
•Malignancy within the last 5 years of screening (except non-melanoma skin cancers or cervical carcinoma in situ).
+11 more criteria

Locations (90)

Research Site

Beijing, Beijing Municipality, China

Research Site

Lanzhou, Gansu, China

Research Site

Guangzhou, Guangdong, China

Research Site

Guangzhou, Guangdong, China

Research Site

Guangzhou, Guangdong, China

Research Site

Guangzhou, Guangdong, China

Research Site

Guangzhou, Guangdong, China

Research Site

Shenzhen, Guangdong, China

Research Site

Zhanjiang, Guangdong, China

Research Site

Nanning, Guangxi, China

Key Dates

Start Date

May 15, 2018

Primary Completion Date

April 8, 2020

Completion Date

April 8, 2020

Last Updated

April 30, 2021

Enrollment

637

ACTUAL participants

Conditions

Secondary HyperparathyroidismChronic Kidney Disease

Interventions

Etelcalcetide

DRUG

Cinacalcet

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)

Inclusion Criteria

Exclusion Criteria

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A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

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