Safety, Tolerability and Efficacy of Etelcalcetide in Hem... | NCT01254565 | Trialant
NCT01254565
Sponsor
KAI Pharmaceuticals
Status
Completed
Last Update Posted
Apr 13, 2017Actual
Enrollment
87Actual
Phase
Phase 2
Conditions
Secondary Hyperparathyroidism
Interventions
Etelcalcetide
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT01254565
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KAI-4169-003
Secondary IDs
ID
Type
Description
Link
20120330
Other Identifier
Amgen, Inc
Brief Title
Safety, Tolerability and Efficacy of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Official Title
A Double-Blind, Randomized, Placebo-Controlled Multiple Ascending Dose Study to Assess the Safety, Tolerability and Efficacy of KAI-4169 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Acronym
Not provided
Organization
KAI PharmaceuticalsINDUSTRY
Status Module
Record Verification Date
Mar 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 20, 2011
Primary Completion Date
Jul 2011Actual
Completion Date
Aug 24, 2011Actual
First Submitted Date
Dec 3, 2010
First Submission Date that Met QC Criteria
Dec 3, 2010
First Posted Date
Dec 6, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 1, 2017
Results First Submitted that Met QC Criteria
Mar 1, 2017
Results First Posted Date
Apr 13, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jul 8, 2015
Certification/Extension First Submitted that Passed QC Review
Jul 8, 2015
Certification/Extension First Posted Date
Jul 30, 2015Estimated
Last Update Submitted Date
Mar 1, 2017
Last Update Posted Date
Apr 13, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
KAI PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to characterize the safety and tolerability and efficacy of multiple ascending doses of etelcalcetide in hemodialysis patients for the treatment of secondary hyperparathyroidism (HPT).
Detailed Description
Not provided
Conditions Module
Conditions
Secondary Hyperparathyroidism
Keywords
Clinical Trial, Phase 2
Renal Dialysis
Secondary Hyperparathyroidism
Parathyroid hormone
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
87Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Etelcalcetide
Experimental
Participants received etelcalcetide administered by intravenous injection at the end of each hemodialysis session three times a week (TIW). The starting dose level was 5 mg; dose escalation was to proceed to 10 and 20 mg pending safety review of the prior cohort.
Drug: Etelcalcetide
Placebo
Placebo Comparator
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW).
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Etelcalcetide
Drug
Administered intravenously (IV) at the end of hemodialysis
Etelcalcetide
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subject provides written informed consent.
Intact parathyroid hormone (PTH) at least 350 pg/mL.
Corrected calcium at least 9.0 mg/dL.
Hemoglobin at least 9.0 g/dL.
Adequate hemodialysis three times per week.
Excepting chronic renal failure, subject is judged to be in stable medical condition based on medical history, physical examination, and routine laboratory tests.
Exclusion Criteria:
History or symptomatic ventricular dysrhythmias.
History of angina pectoris or congestive heart failure
History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months.
History of or treatment for seizure disorder.
Recent (3 months) parathyroidectomy.
Serum transaminases (alanine aminotransferase, aspartate aminotransferase) greater than two times the upper limit of normal at screening.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
M D
Amgen
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Azusa
California
91702
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
This was a multiple-ascending dose study consisting of 3 cohorts: Cohort 1 participants were randomized in a 3:2 ratio to receive etelcalcetide or placebo for 2 weeks; Cohorts 2 and 3 were randomized in a 1:1 ratio to receive etelcalcetide or placebo for 4 weeks. Randomization was stratified by serum parathyroid hormone (< 600 or ≥ 600 pg/mL).
Recruitment Details
This study was conducted at 11 study centers in the United States from 17 February 2011 (first participant enrolled) to 24 August 2011 (last participant completed follow up). A total of 87 patients with secondary hyperparathyroidism (HPT) receiving hemodialysis were enrolled and randomized in the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
FG001
Cohort 1: Etelcalcetide 5 mg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
KAI-4169
AMG 416
Parsabivâ„¢
Placebo
Drug
Administered intravenously at the end of hemodialysis
Placebo
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase
Efficacy assessment phase
Costa Mesa
California
92626
United States
Lynwood
California
90262
United States
Riverside
California
92505
United States
San Diego
California
92123
United States
Denver
Colorado
80218
United States
Macon
Georgia
31217
United States
Shreveport
Louisiana
71101
United States
Brooklyn Center
Minnesota
55430
United States
Philadelphia
Pennsylvania
19106
United States
Houston
Texas
77004
United States
Houston
Texas
77099
United States
Chesapeake
Virginia
23320
United States
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
FG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
FG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
FG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
FG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
FG0005 subjects
FG0017 subjects
FG00221 subjects
FG00321 subjects
FG00416 subjects
FG00517 subjects
Received Treatment
FG0004 subjects
FG0016 subjects
FG00221 subjects
FG00321 subjects
FG00413 subjects
FG00513 subjects
COMPLETED
FG0004 subjects
FG0016 subjects
FG00221 subjects
FG00320 subjects
FG00412 subjects
FG00513 subjects
NOT COMPLETED
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0044 subjects
FG0054 subjects
Type
Comment
Reasons
Non-compliance to Study Procedures
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
Did not Receive Treatment
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
All randomized participants who received at least one 1 dose of investigational product (the modified intent-to-treat [mITT] population)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
BG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
BG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
BG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
BG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
BG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Corrected calcium data were missing for 2 participants in Cohort 3.
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
ParticipantsBG0004
ParticipantsBG0016
ParticipantsBG002
Phosphorus
Phosphorus values were not collected at Baseline for Cohort 1; data were missing for 7 participants in Cohort 2 and 2 participants in Cohort 3.
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percent Change From Baseline in Mean Pre-hemodialysis Parathyroid Hormone (PTH) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Modified intent-to-treat population
Posted
Mean
Standard Deviation
percent change
Baseline and the efficacy assessment phase (EAP; defined as the period between 3 days before and 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
OG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
OG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Units
Counts
Participants
OG0004
OG0016
OG00221
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.3± 17.11
OG001-19.4± 20.65
OG00228.5± 70.39
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.
ANOVA
A rank analysis of variance (ANOVA) model with treatment and screening PTH (< 600 pg/mL or ≥ 600 pg/mL) as factors.
<0.0001
LS Mean Difference
-76.9
2-Sided
95
-86.9
-50.0
Secondary
Percentage of Participants With ≥ 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Modified intent-to-treat population
Posted
Number
percentage of participants
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
OG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
OG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Secondary
Percentage of Participants With Mean Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase
The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Modified intent-to-treat population
Posted
Number
percentage of participants
Efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
OG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
OG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG003
Secondary
Percent Change From Baseline in Mean Corrected Calcium (cCa) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Modified intent-to-treat population with available data
Posted
Mean
Standard Deviation
percent change
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
OG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
OG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Secondary
Percent Change From Baseline in Mean Phosphorus (P) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.
Posted
Mean
Standard Deviation
percent change
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
OG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
OG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Secondary
Percent Change From Baseline in Corrected Calcium Phosphorus Product (cCa x P) During the Efficacy Assessment Phase
Baseline is defined as the average of pre-hemodialysis values obtained on day -2 and day 1. The efficacy assessment phase (defined as 3 days before and 3 days after the last dose of investigational product) value is the mean of all predialysis values obtained during that period.
Modified intent-to-treat population with available data; Phosphorus data were not collected at baseline for participants in Cohort 1.
Posted
Mean
Standard Deviation
percent change
Baseline and the efficacy assessment phase (from 3 days before to 3 days after the last dose of study drug; approximately 2 weeks for Cohort 1 and 4 weeks for Cohorts 2 and 3)
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
OG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
OG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Secondary
Percentage of Participants With Mean Phosphorus ≤ 4.5 mg/dL or ≤ 5.5 mg/dL During the Efficacy Assessment Phase
Modified intent to treat population
Posted
Number
percentage of participants
Efficacy assessment phase
ID
Title
Description
OG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
OG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
OG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Time Frame
From first dose of study drug through to day 41 (Cohort 1) or day 55 (Cohorts 2 and 3).
Description
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
0
4
1
4
EG001
Cohort 1: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
1
6
4
6
EG002
Cohort 2: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
2
21
5
21
EG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
3
21
2
21
EG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
1
13
2
13
EG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
3
13
3
13
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina pectoris
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG0030 affected21 at risk
EG0040 affected13 at risk
EG0051 affected13 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Arteriovenous graft site infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Vascular graft thrombosis
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Fluid overload
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG0030 affected21 at risk
EG0040 affected13 at risk
EG0050 affected13 at risk
Palpitations
Cardiac disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Eye pain
Eye disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Wound infection
Infections and infestations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Joint sprain
Injury, poisoning and procedural complications
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected6 at risk
EG0020 affected21 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0023 affected21 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0021 affected21 at risk
EG003
Headache
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Urine odour abnormal
Renal and urinary disorders
MedDRA 13.1
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hypertension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Hypotension
Vascular disorders
MedDRA 13.1
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected6 at risk
EG0020 affected21 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Amgen, Inc
866-572-6436
ID
Term
D006962
Hyperparathyroidism, Secondary
Ancestor Terms
ID
Term
D006961
Hyperparathyroidism
D010279
Parathyroid Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C583569
etelcalcetide hydrochloride
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
3 subjects
FG0054 subjects
0 subjects
FG0050 subjects
21
ParticipantsBG00413
ParticipantsBG00513
ParticipantsBG00678
Title
Measurements
BG00047.8± 16.66
BG00154.0± 10.00
BG00252.4± 13.65
BG00350.7± 13.60
BG00456.7± 11.61
BG00559.6± 10.99
BG00653.7± 12.88
21
ParticipantsBG00321
ParticipantsBG00413
ParticipantsBG00513
ParticipantsBG00678
Title
Measurements
Female
BG0002
BG0014
BG0028
BG0036
BG0045
BG0055
BG00630
Male
BG0002
BG0012
BG00213
BG00315
BG004
21
ParticipantsBG00321
ParticipantsBG00413
ParticipantsBG00513
ParticipantsBG00678
Title
Measurements
White
BG0002
BG0011
BG0021
BG0033
BG0044
BG0054
BG00615
Black or African American
BG0002
BG0015
BG00220
BG00318
BG004
21
ParticipantsBG00321
ParticipantsBG00413
ParticipantsBG00513
ParticipantsBG00678
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0020
BG0032
BG0042
BG0053
BG0068
Not Hispanic or Latino
BG0004
BG0015
BG00221
BG00319
BG004
21
ParticipantsBG00321
ParticipantsBG00413
ParticipantsBG00513
ParticipantsBG00678
Title
Measurements
< 600 pg/mL
BG0003
BG0014
BG00211
BG00312
BG0047
BG0059
BG00646
≥ 600 pg/mL
BG0001
BG0012
BG00210
BG0039
BG004
21
ParticipantsBG00321
ParticipantsBG00413
ParticipantsBG00513
ParticipantsBG00678
Title
Measurements
BG000636.3± 191.64
BG001588.3± 250.52
BG002601.5± 239.20
BG003765.1± 480.82
BG004619.4± 310.35
BG005662.1± 442.01
BG006659.4± 361.28
21
ParticipantsBG00321
ParticipantsBG00412
ParticipantsBG00512
ParticipantsBG00676
Title
Measurements
BG0009.1± 0.84
BG0019.3± 0.44
BG0029.8± 0.62
BG0039.7± 0.59
BG0049.3± 0.58
BG0059.7± 0.62
BG0069.6± 0.63
18
ParticipantsBG00317
ParticipantsBG00412
ParticipantsBG00512
ParticipantsBG00659
Title
Measurements
BG0026.5± 1.83
BG0035.7± 1.18
BG0045.2± 1.17
BG0055.0± 1.02
BG0065.7± 1.49
21
OG00413
OG00513
-49.4
± 20.42
OG0042.3± 29.44
OG005-33.0± 26.28
Superiority
The primary endpoint was tested at the 0.05 level (1-sided).
OG004
OG005
The hypothesis for this study (Cohorts 2 and 3) was that intravenous administration of etelcalcetide is superior to placebo for the reduction of PTH after TIW dosing in hemodialysis patients with secondary HPT. This hypothesis was tested in Cohorts 2 and 3 by comparing the mean percent changes from baseline in pre-hemodialysis PTH levels collected during the efficacy phase between the etelcalcetide and placebo groups within each cohort.
ANOVA
ANOVA model with treatment and screening PTH (< 600 pg/mL or ≥ 600 pg/mL) as factors.
0.0032
LS Mean Difference
-36.7
2-Sided
95
-59.8
-13.6
Superiority
The primary endpoint was tested at the 0.05 level (1-sided).
OG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Units
Counts
Participants
OG0004
OG0016
OG00221
OG00321
OG00413
OG00513
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00133.3
OG0029.5
OG00376.2
OG00415.4
OG00553.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
Fisher Exact
<0.0001
Superiority
OG004
OG005
Fisher Exact
0.0968
Superiority
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Units
Counts
Participants
OG0004
OG0016
OG00221
OG00321
OG00413
OG00513
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00116.7
OG0024.8
OG00366.7
OG0047.7
OG00546.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
Fisher Exact
<0.0001
Superiority
OG004
OG005
Fisher Exact
0.0730
Superiority
OG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Units
Counts
Participants
OG0004
OG0016
OG00221
OG00321
OG00412
OG00512
Title
Denominators
Categories
Title
Measurements
OG0001.7± 3.76
OG001-7.3± 2.62
OG002-1.7± 6.25
OG003-13.0± 10.17
OG0041.0± 5.26
OG005-6.0± 7.95
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
ANOVA
A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.
< 0.0001
LS Mean Difference
-11.3
2-Sided
95
-16.4
-8.4
Superiority
OG004
OG005
ANOVA
ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.
0.0235
LS Mean Difference
-6.9
2-Sided
95
-12.8
-1.0
Superiority
OG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Units
Counts
Participants
OG0000
OG0010
OG00217
OG00317
OG00412
OG00512
Title
Denominators
Categories
Title
Measurements
OG0021.4± 17.92
OG003-2.4± 26.86
OG00414.1± 36.05
OG005-7.3± 12.83
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
ANOVA
A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.
0.2255
LS Mean Difference
-4.2
2-Sided
95
-18.6
5.7
Superiority
OG004
OG005
ANOVA
A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.
0.1751
LS mean Difference
-21.8
2-Sided
95
-29.8
5.9
Superiority
OG003
Cohort 2: Etelcalcetide 10 mg
Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
Units
Counts
Participants
OG0000
OG0010
OG00217
OG00317
OG00412
OG00512
Title
Denominators
Categories
Title
Measurements
OG002-0.3± 16.25
OG003-11.0± 32.32
OG00414.7± 35.79
OG005-12.6± 14.99
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
ANOVA
A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.
0.0112
LS Mean Difference
-11.2
2-Sided
95
-26.8
-4.9
Superiority
OG004
OG005
ANOVA
A rank ANOVA model with treatment and screening PTH (< 600 or ≥ 600 pg/mL) as factors.
0.0554
LS Mean Difference
-27.7
2-Sided
95
-39.3
-1.6
Superiority
OG004
Cohort 3: Placebo
Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
OG005
Cohort 3: Etelcalcetide 5 mg
Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.