Trial · NCT01785875

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

NCT01785875, Phase 3, Completed, Amgen; results first posted 2017-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis. Trials, record NCT01785875. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785875

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Trial

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

Title: Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
NCT number: NCT01785875
Status: Completed
Phases: Phase 3
Enrollment: 891 participants, actual
Lead sponsor: Amgen
Conditions: Hyperparathyroidism, Secondary
Interventions: Etelcalcetide
First posted: 2013-02-07
Last updated: 2019-04-10
Other registries' IDs: eudract:2012-002808-41
Results first posted: 2017-03-27

Source ClinicalTrials.gov

Registered outcomes16

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Adverse Events (AEs)	From first dose until 30 days after last dose; the treatment period was 52 weeks.	Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event.
Primary	Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4	52 weeks	Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated.
Primary	Number of Participants Who Developed Anti-etelcalcetide Antibodies	Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit	A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported.
Primary	Change From Baseline in Blood Pressure	Baseline and Weeks 24 and 48	Blood pressure (BP) values were taken post-hemodialysis assessments.
Secondary	Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase	Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)	The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged.
Secondary	Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12	Baseline and the efficacy assessment phase at month 12 (weeks 46-53)	The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged.
Secondary	Percentage of Participants With PTH ≤ 300 pg/mL During the EAP	Baseline and the efficacy assessment phase
Secondary	Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12	Week 46 to 53
Secondary	Percent Change From Baseline in Mean PTH During the EAP	Baseline and the efficacy assessment phase
Secondary	Percent Change From Baseline in Mean PTH During the EAP12	Baseline and the efficacy assessment phase at month 12 (weeks 46-53)

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

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 (AEs)	From first dose until 30 days after last dose; the treatment period was 52 weeks.	All participants who received at least 1 dose of etelcalcetide.	participants	NUMBER
PRIMARY	Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4	52 weeks	All participants who received at least 1 dose of etelcalcetide.	participants	NUMBER
PRIMARY	Number of Participants Who Developed Anti-etelcalcetide Antibodies	Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit	Participants who received at least 1 dose of etelcalcetide and with a post-baseline antibody result.	participants	NUMBER
SECONDARY	Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase	Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment)	Participants with pre-dialysis PTH assessment at baseline and during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12	Baseline and the efficacy assessment phase at month 12 (weeks 46-53)	Participants with pre-dialysis PTH assessment at baseline and during EAP12	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With PTH ≤ 300 pg/mL During the EAP	Baseline and the efficacy assessment phase	Participants with predialysis PTH assessment during the EAP who completed a minimum of 8 weeks of treatment with etelcalcetide	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12	Week 46 to 53	Participants with predialysis PTH assessment during the EAP12	percentage of participants	NUMBER
SECONDARY	Percent Change From Baseline in Mean PTH During the EAP	Baseline and the efficacy assessment phase	Participants with available data	percent change	MEAN
SECONDARY	Percent Change From Baseline in Mean PTH During the EAP12	Baseline and the efficacy assessment phase at month 12 (weeks 46-53)	Participants with available data	percent change	MEAN
SECONDARY	Percent Change From Baseline in Mean Corrected Calcium During the EAP	Baseline and the efficacy assessment phase	Participants with available data	percent change	MEAN

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group104

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 (AEs)	20120229 / 20120230 Placebo	Any adverse event	354	participants
Number of Participants With Adverse Events (AEs)	20120229 / 20120230 Etelcalcetide	Any adverse event	337	participants
Number of Participants With Adverse Events (AEs)	20120359 Etelcalcetide	Any adverse event	108	participants
Number of Participants With Adverse Events (AEs)	Etelcalcetide Total	Any adverse event	799	participants
Number of Participants With Adverse Events (AEs)	20120229 / 20120230 Placebo	Serious adverse events	161	participants
Number of Participants With Adverse Events (AEs)	20120229 / 20120230 Etelcalcetide	Serious adverse events	142	participants
Number of Participants With Adverse Events (AEs)	20120359 Etelcalcetide	Serious adverse events	53	participants
Number of Participants With Adverse Events (AEs)	Etelcalcetide Total	Serious adverse events	356	participants
Number of Participants With Adverse Events (AEs)	20120229 / 20120230 Placebo	Treatment-related adverse events	215	participants
Number of Participants With Adverse Events (AEs)	20120229 / 20120230 Etelcalcetide	Treatment-related adverse events	141	participants

1 to 10 of 104Source ClinicalTrials.gov

See all 104 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	20120229 / 20120230 Placebo	384
Overall Study	STARTED	20120229 / 20120230 Etelcalcetide	384
Overall Study	STARTED	20120359 Etelcalcetide	123
Overall Study	Received Etelcalcetide	20120229 / 20120230 Placebo	383
Overall Study	Received Etelcalcetide	20120229 / 20120230 Etelcalcetide	384
Overall Study	Received Etelcalcetide	20120359 Etelcalcetide	123
Overall Study	COMPLETED	20120229 / 20120230 Placebo	90
Overall Study	COMPLETED	20120229 / 20120230 Etelcalcetide	95
Overall Study	COMPLETED	20120359 Etelcalcetide	16
Overall Study	NOT COMPLETED	20120229 / 20120230 Placebo	294

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events1,612

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	Abdominal pain	Gastrointestinal disorders	20120229 / 20120230 Placebo	22	383
other	Abdominal pain	Gastrointestinal disorders	20120229 / 20120230 Etelcalcetide	12	384
other	Abdominal pain	Gastrointestinal disorders	20120359 Etelcalcetide	3	123
other	Abdominal pain	Gastrointestinal disorders	Total	37	890
other	Diarrhoea	Gastrointestinal disorders	20120229 / 20120230 Placebo	41	383
other	Diarrhoea	Gastrointestinal disorders	20120229 / 20120230 Etelcalcetide	46	384
other	Diarrhoea	Gastrointestinal disorders	20120359 Etelcalcetide	8	123
other	Diarrhoea	Gastrointestinal disorders	Total	95	890
other	Nausea	Gastrointestinal disorders	20120229 / 20120230 Placebo	43	383
other	Nausea	Gastrointestinal disorders	20120229 / 20120230 Etelcalcetide	27	384

1 to 10 of 1,612Source ClinicalTrials.gov

See all 1,612 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	20120229 / 20120230 Placebo
Total, all-cause mortality	20120229 / 20120230 Etelcalcetide
Total, all-cause mortality	20120359 Etelcalcetide
Total, all-cause mortality	Total
Total, other adverse events	20120229 / 20120230 Placebo	289	383
Total, other adverse events	20120229 / 20120230 Etelcalcetide	249	384
Total, other adverse events	20120359 Etelcalcetide	75	123
Total, other adverse events	Total	613	890
Total, serious adverse events	20120229 / 20120230 Placebo	161	383
Total, serious adverse events	20120229 / 20120230 Etelcalcetide	142	384

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30859218	DERIVED	PubMed
30875390	BACKGROUND	PubMed

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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