Trial · NCT03299244
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| OTHER_PRE_SPECIFIED | Number of Participants With Treatment-emergent Adverse Events | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT03299244/outcomes