A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis

• ClinicalTrials.gov Identifier: NCT02833857
• Recruitment Status: Completed
• First Posted: July 14, 2016
• Results First Posted: July 10, 2019
• Last Update Posted: July 10, 2019
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

• Study Type: Interventional
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Kidney Disease, Secondary Hyperparathyroidism
• Intervention: Drug: Etelcalcetide
• Enrollment: 11

Participant Flow

Recruitment Details	This study was conducted at 6 centers in the United States, United Kingdom, and the European Union. Participants were enrolled from 14 March 2017 to 01 October 2018.
Pre-assignment Details

Arm/Group Title	Etelcalcetide
Arm/Group Description	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Period Title: Overall Study
Started	11
Completed	11
Not Completed	0

Baseline Characteristics

Arm/Group Title		Etelcalcetide
Arm/Group Description		Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Baseline Participants		11
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	11 participants
		10.3 (4.3)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants
	Children (2 to 11 years)	5 45.5%
	Adolescents (12 to 17 years)	6 54.5%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants
	Female	6 54.5%
	Male	5 45.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants
	Hispanic or Latino	2 18.2%
	Not Hispanic or Latino	9 81.8%
	Unknown or Not Reported	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	11 participants
	Black (or African American)	2 18.2%
	White	9 81.8%
Serum Corrected Calcium Concentration [1]; Mean (Standard Deviation); Unit of measure: mmol/L
	Number Analyzed	11 participants
		2.42 (0.08)
		[1] Measure Description: When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 – serum albumin [g/L]).
Serum Phosphorus Concentration [1]; Mean (Standard Deviation); Unit of measure: mmol/L
	Number Analyzed	10 participants
		1.79 (0.45)
		[1] Measure Analysis Population Description: Participants with available data
Serum Potassium Concentration; Mean (Standard Deviation); Unit of measure: mmol/L
	Number Analyzed	11 participants
		4.77 (0.55)
Serum Intact Parathyroid Hormone Concentration; Mean (Standard Deviation); Unit of measure: pmol/L
	Number Analyzed	11 participants
		66.10 (57.57)
Serum Calcium Concentration; Mean (Standard Deviation); Unit of measure: mmol/L
	Number Analyzed	11 participants
		2.41 (0.08)
Serum Ionized Calcium Concentration; Mean (Standard Deviation); Unit of measure: mmol/L
	Number Analyzed	11 participants
		1.16 (0.07)
Heart Rate; Mean (Standard Deviation); Unit of measure: Beats/minute
	Number Analyzed	11 participants
		87.4 (9.9)
Temperature; Mean (Standard Deviation); Unit of measure: Degrees celsius
	Number Analyzed	11 participants
		36.6 (0.3)
Blood Pressure; Mean (Standard Deviation); Unit of measure: mmHg
Systolic blood pressure	Number Analyzed	11 participants
		119.4 (15.9)
Diastolic blood pressure	Number Analyzed	11 participants
		66.7 (15.1)
PR Interval [1]; Mean (Standard Deviation); Unit of measure: Ms
	Number Analyzed	11 participants
		133.8 (8.7)
		[1] Measure Description: The PR interval is measured using electrocardiography (ECG) and is the period from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization); it is normally between 120 and 200 milliseconds (ms) in duration.
QRS Interval [1]; Mean (Standard Deviation); Unit of measure: Ms
	Number Analyzed	11 participants
		82.0 (10.9)
		[1] Measure Description: The QRS interval measured during ECG, denotes depolarization of the ventricles, between the beginning of the Q wave and the end of the S wave.
QT Interval [1]; Mean (Standard Deviation); Unit of measure: Ms
	Number Analyzed	11 participants
		363.5 (26.2)
		[1] Measure Description: The QT interval measured during ECG is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QT interval represents electrical depolarization and repolarization of the ventricles.
Corrected (Bazett) QT Interval (QTcB); Mean (Standard Deviation); Unit of measure: Ms
	Number Analyzed	11 participants
		424.2 (29.1)
Corrected (Fridericia) QT Interval (QTcF); Mean (Standard Deviation); Unit of measure: Ms
	Number Analyzed	11 participants
		402.7 (26.1)

Outcome Measures

1. Primary Outcome

Title	Common Treatment-emergent Adverse Events
Description	A treatment-emergent adverse event is any adverse event (AE) that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. Common adverse events were defined as adverse events occurring in at least 2 participants. The Medical Dictionary for Regulatory Activities (MedDRA) version 21.0 was used for coding all adverse events.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of etelcalcetide (safety analysis set)

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Measure Type: Count of Participants; Unit of Measure: Participants
Headache	2 18.2%
Calcium ionised decreased	2 18.2%
Hypotension	2 18.2%

2. Primary Outcome

Title	Change From Baseline in Serum Corrected Calcium Concentration Over Time
Description	When albumin was less than 4.0 mg/dL, the calcium concentration was corrected according to the formula: cCa (mmol/L) = measured total serum calcium (mmol/L) + 0.02 (40 – serum albumin [g/L]).
Time Frame	Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants with available data at each time point.

Arm/Group Title		Etelcalcetide
Arm/Group Description:		Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed		11
Mean (Standard Deviation); Unit of Measure: mmol/L
Day 1, 4 hours	Number Analyzed	10 participants
		-0.03 (0.12)
Day 3	Number Analyzed	11 participants
		-0.03 (0.08)
Day 8	Number Analyzed	11 participants
		0.03 (0.09)
Day 10	Number Analyzed	11 participants
		0.03 (0.07)
Day 30	Number Analyzed	11 participants
		-0.01 (0.16)

3. Primary Outcome

Title	Change From Baseline in Serum Phosphorus Concentration at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.08 (0.31)

4. Primary Outcome

Title	Change From Baseline in Serum Potassium Concentration at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: mmol/L
	0.45 (1.21)

5. Primary Outcome

Title	Change From Baseline in Intact Parathyroid Hormone (iPTH) Levels Over Time
Description	[Not Specified]
Time Frame	Baseline and day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants with available data at each time point.

Arm/Group Title		Etelcalcetide
Arm/Group Description:		Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed		11
Mean (Standard Deviation); Unit of Measure: pmol/L
Day 1, 4 hours	Number Analyzed	10 participants
		-29.44 (37.16)
Day 3	Number Analyzed	11 participants
		-14.81 (37.81)
Day 8	Number Analyzed	11 participants
		-10.20 (38.16)
Day 10	Number Analyzed	11 participants
		-4.68 (37.92)
Day 30	Number Analyzed	11 participants
		-19.81 (51.29)

6. Primary Outcome

Title	Change From Baseline in Heart Rate at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: beats/minute
	-4.5 (9.3)

7. Primary Outcome

Title	Change From Baseline in Temperature at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: degrees celsius
	0.1 (0.4)

8. Primary Outcome

Title	Change From Baseline in Blood Pressure at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: mmHg
Systolic blood pressure	0.2 (17.5)
Diastolic blood pressure	3.8 (8.5)

9. Primary Outcome

Title	Change From Baseline in PR Interval at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: ms
	-3.6 (13.9)

10. Primary Outcome

Title	Change From Baseline in QRS Interval at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: ms
	-2.6 (6.8)

11. Primary Outcome

Title	Change From Baseline in QT Interval at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: ms
	2.8 (21.6)

12. Primary Outcome

Title	Change From Baseline in Corrected (Bazett) QT Interval at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: ms
	-2.1 (32.2)

13. Primary Outcome

Title	Change From Baseline in Corrected (Fridericia) QT Interval at End of Study
Description	[Not Specified]
Time Frame	Baseline and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: ms
	-0.5 (23.3)

14. Secondary Outcome

Title	Change From Baseline in Serum Total Calcium Concentration
Description	[Not Specified]
Time Frame	Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants with available data at each time point.

Arm/Group Title		Etelcalcetide
Arm/Group Description:		Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed		11
Mean (Standard Deviation); Unit of Measure: mmol/L
Day 1, 4 hours	Number Analyzed	10 participants
		-0.02 (0.12)
Day 3	Number Analyzed	11 participants
		-0.02 (0.08)
Day 8	Number Analyzed	11 participants
		0.03 (0.08)
Day 10	Number Analyzed	11 participants
		0.02 (0.08)
Day 30	Number Analyzed	11 participants
		-0.01 (0.16)

15. Secondary Outcome

Title	Change From Baseline in Serum Ionized Calcium Concentration
Description	[Not Specified]
Time Frame	Baseline and Day 1, 4 hours postdose, day 3, day 8, day 10, and day 30 (end of study)

Outcome Measure Data

Analysis Population Description

Treated participants with available data at each time point.

Arm/Group Title		Etelcalcetide
Arm/Group Description:		Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed		11
Mean (Standard Deviation); Unit of Measure: mmol/L
Day 1, 4 hours	Number Analyzed	10 participants
		-0.05 (0.13)
Day 3	Number Analyzed	10 participants
		-0.01 (0.08)
Day 8	Number Analyzed	11 participants
		0.02 (0.07)
Day 10	Number Analyzed	11 participants
		0.01 (0.06)
Day 30	Number Analyzed	11 participants
		0.03 (0.06)

16. Secondary Outcome

Title	Maximum Observed Plasma Concentration (Cmax) of Etelcalcetide
Description	Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Time Frame	10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

Outcome Measure Data

Analysis Population Description

The pharmacokinetic analysis set

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: ng/mL
	50.8 (29.3)

17. Secondary Outcome

Title	Time to Maximum Concentration (Tmax) of Etelcalcetide
Description	Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL.
Time Frame	10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

Outcome Measure Data

Analysis Population Description

The pharmacokinetic concentration analysis set was composed of all participants who received etelcalcetide and had at least 1 pharmacokinetic sample collected.

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Median (Full Range); Unit of Measure: hours
	0.17; (0.17 to 0.33)

18. Secondary Outcome

Title	Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast)
Description	Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Area under the curve for plasma etelcalcetide from time zero to the last quantifiable concentration (AUClast) was estimated using the linear trapezoidal method.
Time Frame	10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: hr*ng/mL
	1360 (1110)

19. Secondary Outcome

Title	Area Under the Plasma Etelcalcetide Concentration-Time Curve From Time Zero Infinity (AUCinf)
Description	Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Area under the concentration-time curve from time zero to infinite time (AUCinf) was estimated using the linear trapezoidal method.
Time Frame	10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set with available AUCinf data

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: hr*ng/mL
	1700 (1420)

20. Secondary Outcome

Title	Terminal Half-life (T1/2,z) of Etelcalcetide
Description	Plasma etelcalcetide concentrations were measured using a validated high performance liquid chromatography assay. The lower limit of quantitation was 0.200 ng/mL. Terminal half life of plasma etelcalcetide (t1/2,z) was calculated as t1/2,z = ln(2)/λz, where λz is the first-order terminal rate constant estimated by linear regression of the terminal log-linear phase.
Time Frame	10 minutes, 4 hours, and 3, 5, 8, 10, and 30 days postdose

Outcome Measure Data

Analysis Population Description

Pharmacokinetic analysis set with available T1/2,z data

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	7
Mean (Standard Deviation); Unit of Measure: days
	5.77 (2.66)

21. Secondary Outcome

Title	Number of Participants Who Developed Anti-etelcalcetide Binding Antibodies
Description	Samples were collected predose and at end of study (day 30) and tested for anti etelcalcetide binding antibodies using a validated immunoassay. Developing antibody binding was defined as participants who were binding antibody positive postbaseline with a negative result at baseline.
Time Frame	Baseline and day 30

Outcome Measure Data

Analysis Population Description

Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Measure Type: Count of Participants; Unit of Measure: Participants
	2 18.2%

22. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events
Description	A treatment-emergent adverse event is any adverse event that begins or worsens after the initial dose of study drug (etelcalcetide) and up to 30 days after the last dose. The severity of each adverse event was graded using the National Cancer Institute-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = Mild (asymptomatic or mild symptoms), Grade 2 = Moderate (minimal, local or noninvasive intervention indicated), Grade 3 = Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated, Grade 4 = Life-threatening consequences; urgent intervention indicated, and Grade 5 = Death related to AE.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All Treated participants

Arm/Group Title	Etelcalcetide
Arm/Group Description:	Participants received a single, intravenous (IV) bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Overall Number of Participants Analyzed	11
Measure Type: Count of Participants; Unit of Measure: Participants
Any adverse event	6 54.5%
Adverse events ≥ grade 3	2 18.2%
Adverse events ≥ grade 4	0 0.0%
Serious adverse events	0 0.0%
AEs leading to discontinuation of etelcalcetide	0 0.0%
Fatal adverse events	0 0.0%
Treatment-related adverse events	0 0.0%
Treatment-related AEs ≥ grade 3	0 0.0%

Adverse Events

Time Frame	30 days
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	Etelcalcetide
Arm/Group Description	Participants received a single, intravenous bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
All-Cause Mortality
	Etelcalcetide
	Affected / at Risk (%)
Total	0/11 (0.00%)
Serious Adverse Events
	Etelcalcetide
	Affected / at Risk (%)
Total	0/11 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Etelcalcetide
	Affected / at Risk (%)
Total	6/11 (54.55%)
Gastrointestinal disorders
Nausea † 1	1/11 (9.09%)
Vomiting † 1	1/11 (9.09%)
Investigations
Calcium ionised decreased † 1	2/11 (18.18%)
Nervous system disorders
Dizziness † 1	1/11 (9.09%)
Headache † 1	2/11 (18.18%)
Paraesthesia † 1	1/11 (9.09%)
Surgical and medical procedures
Catheter placement † 1	1/11 (9.09%)
Gastrostomy † 1	1/11 (9.09%)
Vascular disorders
Hypotension † 1	2/11 (18.18%)
1 Term from vocabulary, MedDRA 21.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: Study Director
• Organization: Amgen Inc.
• Phone: 866-572-6436
• EMail: medinfo@amgen.com

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT02833857 History of Changes
• Other Study ID Numbers: 20140336; 2015-005051-28 ( EudraCT Number )
• First Submitted: June 9, 2016
• First Posted: July 14, 2016
• Results First Submitted: April 23, 2019
• Results First Posted: July 10, 2019
• Last Update Posted: July 10, 2019