Comparison · NCT03299244-9f2b0127
Cinacalcet vs Etelcalcetide: Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Cinacalcet vs Etelcalcetide: Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study. Trial comparisons, record NCT03299244-9f2b0127. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03299244-9f2b0127
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0476 | 0.0291 | 0.0771 | wilson | |
| Risk in group 2 | 0.11 | 0.0802 | 0.149 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0624 | -0.106 | -0.0205 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.433 | 0.241 | 0.776 | log | |
| Odds ratio, group 1 over group 2 | 0.404 | 0.216 | 0.756 | log | |
| Number needed to treat, for one fewer participant with the outcome on Cinacalcet than on Etelcalcetide | 16 | 9.45 | 48.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Cinacalcet | Participants were randomized to receive oral cinacalcet once daily and placebo intravenous (IV) bolus injection at the end of each hemodialysis session three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 25 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL. | 15 | 315 | OG000 |
| Group 2 | Etelcalcetide | Participants were randomized to receive etelcalcetide administered by IV bolus injection at the end of each hemodialysis session TIW and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL. | 35 | 318 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Treatment-emergent Symptomatic Hypocalcemia During the Study
- Description
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.
- Time frame
- From first dose of study drug to 30 days after last dose; up to 26 weeks + 30 days.
- Population
- Safety analysis set
Source ClinicalTrials.gov
Trial
- Title
- Head-to-Head Study of Etelcalcetide and Cinacalcet in Asian Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT)
- NCT number
- NCT03299244
- Phases
- PHASE3
- Conditions
- Secondary Hyperparathyroidism, Chronic Kidney Disease
- Interventions
- Etelcalcetide, Cinacalcet
- Lead sponsor
- Amgen
- Results first posted
- 2021-04-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03299244?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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