Trial · NCT03299244
Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
NCT03299244, Phase 3, Completed, Amgen; results first posted 2021-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT). Trials, record NCT03299244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03299244
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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 and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
- NCT number
- NCT03299244
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 637 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- Interventions
- Etelcalcetide, Cinacalcet
- First posted
- 2017-10-03
- Last updated
- 2021-04-30
- Results first posted
- 2021-04-30
Source ClinicalTrials.gov
Registered outcomes11
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 Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Baseline and the efficacy assessment phase (EAP; defined as weeks 20 to 27, inclusive). | Predialysis intact parathyroid hormone (iPTH) levels were measured by a central laboratory. |
| Secondary | Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive). | Predialysis intact parathyroid hormone levels were measured by a central laboratory. |
| Secondary | Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis | Baseline and the efficacy assessment phase (weeks 20 to 27, inclusive) | Predialysis intact parathyroid hormone levels were measured by a central laboratory. |
| Secondary | Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive) | Predialysis corrected calcium was measured by a central laboratory. |
| Secondary | Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | Efficacy assessment phase (weeks 20 - 27, inclusive) | Predialysis serum phosphorus was measured by a central laboratory. |
| Other | Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Corrected calcium was measured by the central laboratory. |
| Other | Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Corrected calcium was measured by the central laboratory. |
| Other | Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Corrected calcium was measured by the central laboratory. |
| Other | Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study | From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. | Common symptoms of hypocalcemia (diminished blood calcium) include paresthesias (fingertips, toes, or perioral), fatigue, muscle cramps, irritability or anxiety, tetany (eg, carpopedal spasm, laryngospasm), Chvostek's sign, seizures, and prolonged QT interval. |
| Other | Number of Participants Who Developed Antibodies to Etelcalcetide | From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. | Developing antibody incidence is defined as participants who were binding antibody positive post-baseline with a negative or no result at baseline. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Predialysis Intact 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 iPTH data during the EAP. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH 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 (non-responder imputation). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis | 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. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase (weeks 20 - 27, inclusive) | Full analysis set; participants 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, inclusive) | Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Participants in the safety analysis set with at least 1 post-baseline cCa value.~The safety analysis set includes all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Participants in the safety analysis set with at least 1 post-baseline cCa value. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study | From first dose of study drug to end of study; up to 26 weeks + 30 days. | Participants in the safety analysis set with at least 1 post-baseline cCa value. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study | From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. | Safety analysis set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants Who Developed Antibodies to Etelcalcetide | From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days. | Safety analysis set participants assigned to etelcalcetide with a post-baseline antibody result. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group35
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 Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Cinacalcet | 66.2 | percentage of participants | ||
| Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis Intact Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis | Etelcalcetide | 71.9 | percentage of participants | ||
| Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase | Cinacalcet | 41.6 | percentage of participants | ||
| Percentage of Participants With > 50% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase | Etelcalcetide | 59.1 | percentage of participants | ||
| Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis | Cinacalcet | 58.0 | percentage of participants | ||
| Percentage of Participants With > 30% Reduction From Baseline in Mean Predialysis iPTH During the Efficacy Assessment Phase - Superiority Analysis | Etelcalcetide | 66.3 | percentage of participants | ||
| Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase | Cinacalcet | -8.00 | Standard Error 0.50 | percent change | |
| Percent Change From Baseline in Mean Predialysis Corrected Calcium During the Efficacy Assessment Phase | Etelcalcetide | -10.69 | Standard Error 0.53 | percent change | |
| Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | Cinacalcet | 26.2 | percentage of participants | ||
| Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase | Etelcalcetide | 29.1 | percentage of participants |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 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 | 317 | |
| Overall Study | STARTED | Etelcalcetide | 320 | |
| Overall Study | Received Treatment | Cinacalcet | 315 | |
| Overall Study | Received Treatment | Etelcalcetide | 318 | |
| Overall Study | COMPLETED | Cinacalcet | 270 | |
| Overall Study | COMPLETED | Etelcalcetide | 282 | |
| Overall Study | NOT COMPLETED | Cinacalcet | 47 | |
| Overall Study | NOT COMPLETED | Etelcalcetide | 38 |
Source ClinicalTrials.gov
Adverse events262
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 | Abdominal discomfort | Gastrointestinal disorders | Cinacalcet | 17 | 315 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Etelcalcetide | 15 | 318 | |
| other | Constipation | Gastrointestinal disorders | Cinacalcet | 12 | 315 | |
| other | Constipation | Gastrointestinal disorders | Etelcalcetide | 18 | 318 | |
| other | Diarrhoea | Gastrointestinal disorders | Cinacalcet | 14 | 315 | |
| other | Diarrhoea | Gastrointestinal disorders | Etelcalcetide | 19 | 318 | |
| other | Nausea | Gastrointestinal disorders | Cinacalcet | 45 | 315 | |
| other | Nausea | Gastrointestinal disorders | Etelcalcetide | 35 | 318 | |
| other | Vomiting | Gastrointestinal disorders | Cinacalcet | 47 | 315 | |
| other | Vomiting | Gastrointestinal disorders | Etelcalcetide | 30 | 318 |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cinacalcet | 9 | 317 |
| Total, all-cause mortality | Etelcalcetide | 4 | 320 |
| Total, other adverse events | Cinacalcet | 293 | 315 |
| Total, other adverse events | Etelcalcetide | 294 | 318 |
| Total, serious adverse events | Cinacalcet | 61 | 315 |
| Total, serious adverse events | Etelcalcetide | 53 | 318 |
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cinacalcet vs Etelcalcetide: Number of Participants With cCa < 7.5 mg/dL At Any Time During the Study | Trial comparisons |
| Cinacalcet vs Etelcalcetide: Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study | Trial comparisons |
| Cinacalcet vs Etelcalcetide: Number of Participants With cCa < 8.0 mg/dL At Any Time During the Study | Trial comparisons |
| Cinacalcet vs Etelcalcetide: deaths from any cause | Trial comparisons |
| Cinacalcet vs Etelcalcetide: Number of Participants With cCa < 8.3 mg/dL At Any Time During the Study | Trial comparisons |
| Cinacalcet vs Etelcalcetide: serious adverse events | 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/NCT03299244
GET https://conductscience.org/api/trials/v1/NCT03299244/results?page=2