Trial · NCT03299244
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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. |
| Other | 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. | An adverse event is defined as any untoward medical occurrence in a clinical study participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment. The investigator assessed whether each adverse event was possibly related to study drug. A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal * life threatening * required in-patient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event |
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.
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