Trial · NCT01896232
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
NCT01896232, Phase 3, Completed, Amgen; results first posted 2017-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet. Trials, record NCT01896232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01896232
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
- NCT number
- NCT01896232
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 683 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- Interventions
- Etelcalcetide, Cinacalcet, Oral Placebo, Intravenous Placebo
- First posted
- 2013-07-11
- Last updated
- 2019-07-18
- Other registries' IDs
- eudract:2013-000192-33
- Results first posted
- 2017-02-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). | |
| Secondary | Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive). | |
| Secondary | Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | |
| Secondary | Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks | First 8 weeks | Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was \> 0 or where the episodes of vomiting score was \> 0. |
| Secondary | Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 - 27) | |
| Secondary | Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | Efficacy assessment phase (weeks 20 - 27) | |
| Secondary | Mean Severity of Nausea in the First 8 Weeks | First 8 weeks | Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks. |
| Secondary | Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks | First 8 weeks | The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis. |
Source ClinicalTrials.gov
Outcomes8
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 > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive). | Full analysis set participants with PTH data during the EAP | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive). | Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (Week 20 to Week 27) | Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation). | percentage of participants | NUMBER |
| SECONDARY | Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks | First 8 weeks | Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis. | days of vomiting or nausea per week | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 - 27) | Full analysis set with available data. | percent change | MEAN |
| SECONDARY | Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | Efficacy assessment phase (weeks 20 - 27) | Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders. | percentage of participants | NUMBER |
| SECONDARY | Mean Severity of Nausea in the First 8 Weeks | First 8 weeks | Full analysis set with available data | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks | First 8 weeks | Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis. | vomiting episodes per week | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group16
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 > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Cinacalcet | 63.9 | percentage of participants | ||
| Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Etelcalcetide | 77.9 | percentage of participants | ||
| Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Cinacalcet | 40.2 | percentage of participants | ||
| Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Etelcalcetide | 52.4 | percentage of participants | ||
| Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Cinacalcet | 57.7 | percentage of participants | ||
| Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase | Etelcalcetide | 68.2 | percentage of participants | ||
| Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks | Cinacalcet | 0.3 | Standard Error 0.03 | days of vomiting or nausea per week | |
| Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks | Etelcalcetide | 0.4 | Standard Error 0.04 | days of vomiting or nausea per week | |
| Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase | Cinacalcet | -6.28 | Standard Error 0.44 | percent change | |
| Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase | Etelcalcetide | -9.83 | Standard Error 0.49 | percent change |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cinacalcet | 343 | |
| Overall Study | STARTED | Etelcalcetide | 340 | |
| Overall Study | Received Treatment | Cinacalcet | 341 | |
| Overall Study | Received Treatment | Etelcalcetide | 338 | |
| Overall Study | COMPLETED | Cinacalcet | 294 | |
| Overall Study | COMPLETED | Etelcalcetide | 287 | |
| Overall Study | NOT COMPLETED | Cinacalcet | 49 | |
| Overall Study | NOT COMPLETED | Etelcalcetide | 53 |
Source ClinicalTrials.gov
Adverse events410
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 | Anaemia | Blood and lymphatic system disorders | Cinacalcet | 11 | 341 | |
| other | Anaemia | Blood and lymphatic system disorders | Etelcalcetide | 17 | 338 | |
| other | Diarrhoea | Gastrointestinal disorders | Cinacalcet | 34 | 341 | |
| other | Diarrhoea | Gastrointestinal disorders | Etelcalcetide | 21 | 338 | |
| other | Nausea | Gastrointestinal disorders | Cinacalcet | 77 | 341 | |
| other | Nausea | Gastrointestinal disorders | Etelcalcetide | 62 | 338 | |
| other | Vomiting | Gastrointestinal disorders | Cinacalcet | 46 | 341 | |
| other | Vomiting | Gastrointestinal disorders | Etelcalcetide | 44 | 338 | |
| other | Blood calcium decreased | Investigations | Cinacalcet | 203 | 341 | |
| other | Blood calcium decreased | Investigations | Etelcalcetide | 232 | 338 |
1 to 10 of 410Source ClinicalTrials.gov
See all 410 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cinacalcet | ||
| Total, all-cause mortality | Etelcalcetide | ||
| Total, other adverse events | Cinacalcet | 259 | 341 |
| Total, other adverse events | Etelcalcetide | 278 | 338 |
| Total, serious adverse events | Cinacalcet | 93 | 341 |
| Total, serious adverse events | Etelcalcetide | 85 | 338 |
Source ClinicalTrials.gov
Papers6
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 |
|---|
| Cinacalcet vs Etelcalcetide: 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/NCT01896232
GET https://conductscience.org/api/trials/v1/NCT01896232/events?page=2