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Clinical Trials List

Protocol Number20150238
NCT Number(ClinicalTrials.gov Identfier)NCT03299244

2018-03-23 - 2020-04-14

Phase III

Terminated13

ICD-10E21

Hyperparathyroidism and other disorders of parathyroid gland

ICD-10E21.1

Secondary hyperparathyroidism, not elsewhere classified

ICD-9252.0

Hyperparathyroidism

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

    Amgen Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator SHUEI-LIONG LIN Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chih-Jen Wu Division of Nephrology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Yen-Chung Lin Division of Nephrology
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 孫樵隱 Division of Nephrology
Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Chia Lee Division of Nephrology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ming-Ju Wu Division of Nephrology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Jin-Bor Chen Division of Nephrology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 甘偉志 Division of Nephrology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 張浤榮 Division of Nephrology
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Junne-Ming Sung Division of Nephrology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 邱炳芳 Division of Nephrology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Mai-Szu Wu Division of Nephrology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 蔡明憲 Division of Nephrology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Secondary Hyperparathyroidism/Hemodialysis

Objectives

Primary Objective: 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 subjects with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis. Secondary Objective: To assess whether treatment with etelcalcetide is superior to treatment with cinacalcet as measured by the proportion of subjects with > 50% decrease in serum PTH from baseline, proportion of subjects with > 30% decrease in serum PTH from baseline, percent change from baseline in mean predialysis albumin corrected calcium (cCa), and achievement of mean predialysis serum phosphorus (P) ≤ 4.5 mg/dl during the efficacy assessment phase (EAP). Safety Objectives: • Assess the safety and tolerability of etelcalcetide compared to cinacalcet • Evaluation of antibody formation to etelcalcetide

Test Drug

Parsabiv

Active Ingredient

AMG 416 (etelcalcetide)

Dosage Form

solution for IV

Dosage

5 mg/mL, 2 ml/vial

Endpoints

Primary Endpoint: The primary endpoint of the study is achievement of a > 30% reduction from
baseline in mean predialysis serum PTH level during the EAP of the study (EAP is defined as
weeks 20 to 27, inclusive).
Key Secondary Endpoint(s):
• Achievement of a > 50% reduction from baseline in mean predialysis serum PTH during the
EAP (superiority)
• Achievement of a > 30% reduction from baseline in mean predialysis serum PTH during the
EAP (superiority)
Other Secondary Endpoints
• Percent change from baseline in mean predialysis serum cCa during the EAP
• Achievement of mean predialysis serum P ≤ 4.5 mg/dL during the EAP
Safety Endpoints
• Incidence of cCa < 8.3 mg/dL at any time during the study
• Incidence of cCa < 8.0 mg/dL at any time during the study
• Incidence of cCa < 7.5 mg/dL at any time during the study
• Incidence of treatment-emergent symptomatic hypocalcemia during the study
• Incidence of antibody formation to etelcalcetide
• Nature, frequency, severity, and relationship of treatment-emergent adverse events.
Exploratory Endpoints
• Percent change from baseline in mean predialysis P during the EAP
• Achievement of mean predialysis serum PTH ≤ 300 pg/mL during the EAP
• Change in serum bone specific alkaline phosphatase (BSAP) from baseline to week 27
• Change in C-telopeptide (CTX) from baseline to week 27

Inclution Criteria

Inclusion Criteria
101 Subject has provided informed consent prior to performing any study-related
activities/procedures.
102 Male or female subjects ≥ 18 years of age or older at the time of signing informed
consent.
103 Subject must be receiving maintenance hemodialysis 3 times weekly for at least
3 months, with adequate hemodialysis with a delivered 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.
104 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.
105 Subject must have SHPT as defined by one central laboratory screening
predialysis serum PTH value > 500 pg/mL, within 2 weeks prior to randomization.
106 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.
107 Subject must have 1 screening predialysis serum cCa laboratory value
≥ 8.3 mg/dL measured within 2 weeks prior to randomization.
108 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.
109 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

Exclusion Criteria
201 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.
202 Subject has received etelcalcetide in a prior clinical trial of etelcalcetide.
203 Subject has received cinacalcet during the 3 months prior to the first screening
laboratory assessments.
204 Subject has known sensitivity to any of the products or components of either
cinacalcet or etelcalcetide to be administered during dosing.
205 Subject has previously been randomized in this study.
206 Anticipated or scheduled parathyroidectomy during the study period.
207 Subject has received a parathyroidectomy within 6 months prior to dosing.
208 Anticipated or scheduled kidney transplant during the study period.
209 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.
210 Malignancy within the last 5 years of screening (except non-melanoma skin
cancers or cervical carcinoma in situ).
211 Grapefruit juice is prohibited.
212 Subject is pregnant or nursing, or planning to become pregnant or nurse during
treatment or within 3 months after the last dose of etelcalcetide or 30 days after the
last dose of cinacalcet.
213 Female subject of childbearing potential who is unwilling to use an acceptable
method of effective contraception during treatment with investigational product (IP)
through 3 months after the last dose of IP. Refer to Section 6.9 for additional
information on pregnancy prevention and definition of woman of childbearing
potential.
214 Subject has a history of symptomatic ventricular dysrhythmias or Torsades de
Pointes.
215 Subject has a history of myocardial infarction, coronary angioplasty, or coronary
arterial bypass grafting within the past 6 months prior to screening.
216 Subject has clinically significant abnormalities on prestudy clinical examination or
abnormalities on the most recent central laboratory tests during the screening
period prior to randomization according to the Investigator including but not limited
to the following:
• serum albumin < 3.0 g/dL
• serum magnesium < 1.5 mg/dL
• serum transaminase (alanine transaminase [ALT] or Serum glutamic
pyruvic transaminase [SGPT], aspartate aminotransferase [AST] or serum
glutamic oxaloacetic transaminase [SGOT]) > 3 times the upper limit of
normal (ULN) at screening
217 Subject likely not available to complete all protocol-required study visits or
procedures, and/or to comply with all required study procedures to the best of the
subject and Investigator’s knowledge.
218 History or evidence of any other clinically significant disorder, condition or disease
(with the exception of those outlined above) that, in the opinion of the Investigator
or Amgen physician, if consulted, would pose a risk to subject safety or interfere
with the study evaluation, procedures or completion.

The Estimated Number of Participants

  • Taiwan

    176 participants

  • Global

    660 participants

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