Trial · NCT02102204

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis

NCT02102204, Phase 3, Completed, Amgen; results first posted 2017-11-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. Trials, record NCT02102204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02102204

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
NCT number: NCT02102204
Status: Completed
Phases: Phase 3
Enrollment: 902 participants, actual
Lead sponsor: Amgen
Conditions: Hyperparathyroidism, Secondary
Interventions: Etelcalcetide
First posted: 2014-04-02
Last updated: 2017-11-17
Other registries' IDs: eudract:2013-004136-30
Results first posted: 2017-11-17

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events	From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.	A serious adverse event is an AE that met at least 1 of the following criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event. The relationship of each AE to study treatment was assessed by the investigator. The following AE grading scale was used: Mild: Transient or mild discomfort; no limitation in activity; no medical intervention/therapy required Moderate: Mild to moderate limitation in activity-some assistance may be needed; no or minimal medical intervention/therapy required Severe: Marked limitation in activity, some assistance usually required; medical intervention/therapy required, hospitalization possible Life-threatening: Extreme limitation in activity, significant assistance required, significant medical intervention/therapy required, hospitalization probable.
Secondary	Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal	Months 6, 12, and 18	The percentage of participants who maintained plasma parathyroid hormone (PTH) levels within the Kidney Disease Improving Global Outcomes (KDIGO) recommended range of not less than 2x the upper limit of normal (ULN) and not greater than 9x the ULN at months 6, 12, and 18, with the ULN based on the reference range of the assay used at the individual clinical site.
Secondary	Percentage of Participants With Serum Phosphorus ≤ the ULN	Months 6, 12, and 18	Percentage of participants with serum phosphorus less than or equal to the upper limit of normal for the assay used.
Secondary	Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL	From day 1 to months 6, 12, and 18	The percentage of participants with serum corrected calcium (cCa) reported for cumulative time intervals from day 1 through months 6, 12, and 18, using the participant's lowest recorded corrected calcium value during the time interval. If serum albumin was less than 4.0 g/dL, serum calcium was corrected according to the following formula: cCa (mg/dL) = total calcium (mg/dL) + (4 - albumin \[g/dL\])\*0.8. If serum albumin was \> 4.0 g/dL no correction was made.
Secondary	Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters	Baseline to end of treatment; median duration of treatment was 563 days.	The Common Terminology Criteria for Adverse Events (CTCAE) grades for laboratory parameter values were defined based on the upper/lower limit of normal from the local laboratories contracted by the study centers.
Secondary	Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies	Baseline and every 6 months (up to 24 months)	The number of participants who were binding antibody positive post-baseline with a negative or no result at baseline (where baseline for participants previously treated with etelcalcetide is Day 1 of the first study in which they were exposed to etelcalcetide and for participants previously treated with cinacalcet is the ending time point for study 20120360).

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Adverse Events	From the date of first dose of etelcalcetide (in the current study) and up to 30 days after the last dose; median duration of treatment was 563 days.	Participants who received at least 1 dose of etelcalcetide in the current study (20130213).	participants	NUMBER
SECONDARY	Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal	Months 6, 12, and 18	Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Serum Phosphorus ≤ the ULN	Months 6, 12, and 18	Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at each time point.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL	From day 1 to months 6, 12, and 18	Participants who received at least 1 dose of etelcalcetide in the current study (20130213) with available data at the beginning of the time interval.	percentage of participants	NUMBER
SECONDARY	Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters	Baseline to end of treatment; median duration of treatment was 563 days.	Participants who received at least 1 dose of etelcalcetide in the current study (20130213).	participants	NUMBER
SECONDARY	Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies	Baseline and every 6 months (up to 24 months)	Participants who received at least 1 dose of etelcalcetide in the current study with a post-baseline antibody result during this study	participants	NUMBER

Source ClinicalTrials.gov

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Adverse Events	Etelcalcetide	Any adverse event	768	participants
Number of Participants With Adverse Events	Etelcalcetide	Serious adverse events	436	participants
Number of Participants With Adverse Events	Etelcalcetide	Treatment-related adverse events	287	participants
Number of Participants With Adverse Events	Etelcalcetide	Serious treatment-related adverse events	4	participants
Number of Participants With Adverse Events	Etelcalcetide	AEs leading to discontinuation of etelcalcetide	41	participants
Number of Participants With Adverse Events	Etelcalcetide	Fatal adverse events	89	participants
Number of Participants With Adverse Events	Etelcalcetide	Mild adverse events	123	participants
Number of Participants With Adverse Events	Etelcalcetide	Moderate adverse events	219	participants
Number of Participants With Adverse Events	Etelcalcetide	Severe adverse events	324	participants
Number of Participants With Adverse Events	Etelcalcetide	Life-threatening adverse events	102	participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow4

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Etelcalcetide	902
Overall Study	Received Etelcalcetide	Etelcalcetide	884
Overall Study	COMPLETED	Etelcalcetide	598
Overall Study	NOT COMPLETED	Etelcalcetide	304

Source ClinicalTrials.gov

Adverse events438

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Etelcalcetide	84	884
other	Nausea	Gastrointestinal disorders	Etelcalcetide	58	884
other	Vomiting	Gastrointestinal disorders	Etelcalcetide	55	884
other	Upper respiratory tract infection	Infections and infestations	Etelcalcetide	58	884
other	Blood calcium decreased	Investigations	Etelcalcetide	251	884
other	Hyperphosphataemia	Metabolism and nutrition disorders	Etelcalcetide	81	884
other	Back pain	Musculoskeletal and connective tissue disorders	Etelcalcetide	51	884
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Etelcalcetide	73	884
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Etelcalcetide	59	884
other	Cough	Respiratory, thoracic and mediastinal disorders	Etelcalcetide	49	884

1 to 10 of 438Source ClinicalTrials.gov

See all 438 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Etelcalcetide
Total, other adverse events	Etelcalcetide	519	884
Total, serious adverse events	Etelcalcetide	436	884

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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