Trial · NCT01785849
Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
NCT01785849, Phase 3, Completed, Amgen; results first posted 2017-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis. Trials, record NCT01785849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785849
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis
- NCT number
- NCT01785849
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 508 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Hyperparathyroidism, Secondary
- Interventions
- Etelcalcetide, Placebo
- First posted
- 2013-02-07
- Last updated
- 2019-08-26
- Other registries' IDs
- eudract:2012-002805-23
- Results first posted
- 2017-03-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). | Participants who did not have any scheduled assessments during the EAP were considered non-responders. |
| Secondary | Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | Participants who had no scheduled assessments during the EAP were considered non-responders. |
| Secondary | Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase | Baseline and the Efficacy Assessment Phase (Week 20 to Week 27) | |
| Secondary | Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | |
| Secondary | Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | |
| Secondary | Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) |
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 | Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). | The full analysis set, consisting of all randomized participants | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase | Baseline and the Efficacy Assessment Phase (Week 20 to Week 27) | Full analysis set participants with observed data | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | Full analysis set participants with observed data | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | Full analysis set participants with observed data | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | Full analysis set participants with observed data | percent change | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase | Placebo | 8.3 | percentage of participants | ||
| Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase | Etelcalcetide | 74.0 | percentage of participants | ||
| Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase | Placebo | 5.1 | percentage of participants | ||
| Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase | Etelcalcetide | 49.6 | percentage of participants | ||
| Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase | Placebo | 13.00 | Standard Error 2.81 | percent change | |
| Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase | Etelcalcetide | -55.11 | Standard Error 1.94 | percent change | |
| Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase | Placebo | 1.18 | Standard Error 0.29 | percent change | |
| Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase | Etelcalcetide | -7.29 | Standard Error 0.53 | percent change | |
| Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase | Placebo | -0.19 | Standard Error 1.44 | percent change | |
| Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase | Etelcalcetide | -14.34 | Standard Error 2.06 | percent change |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 254 | |
| Overall Study | STARTED | Etelcalcetide | 254 | |
| Overall Study | Received Treatment | Placebo | 254 | |
| Overall Study | Received Treatment | Etelcalcetide | 251 | |
| Overall Study | COMPLETED | Placebo | 193 | |
| Overall Study | COMPLETED | Etelcalcetide | 220 | |
| Overall Study | NOT COMPLETED | Placebo | 61 | |
| Overall Study | NOT COMPLETED | Etelcalcetide | 34 |
Source ClinicalTrials.gov
Adverse events368
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 17 | 254 | |
| other | Diarrhoea | Gastrointestinal disorders | Etelcalcetide | 18 | 251 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 13 | 254 | |
| other | Nausea | Gastrointestinal disorders | Etelcalcetide | 31 | 251 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 18 | 254 | |
| other | Vomiting | Gastrointestinal disorders | Etelcalcetide | 25 | 251 | |
| other | Nasopharyngitis | Infections and infestations | Placebo | 13 | 254 | |
| other | Nasopharyngitis | Infections and infestations | Etelcalcetide | 11 | 251 | |
| other | Arteriovenous fistula site complication | Injury, poisoning and procedural complications | Placebo | 14 | 254 | |
| other | Arteriovenous fistula site complication | Injury, poisoning and procedural complications | Etelcalcetide | 11 | 251 |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Etelcalcetide | ||
| Total, other adverse events | Placebo | 110 | 254 |
| Total, other adverse events | Etelcalcetide | 194 | 251 |
| Total, serious adverse events | Placebo | 78 | 254 |
| Total, serious adverse events | Etelcalcetide | 68 | 251 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Etelcalcetide vs Placebo: serious adverse events |
Source Trial comparisons
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.
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.
GET https://conductscience.org/api/trials/v1/NCT01785849
GET https://conductscience.org/api/trials/v1/NCT01785849/events?page=2