Trial · NCT01785875
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | From first dose until 30 days after last dose; the treatment period was 52 weeks. | Treatment-related adverse events are those the investigator indicated as having a reasonable possibility of having been caused by etelcalcetide. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal • life threatening • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • congenital anomaly/birth defect • other medically important serious event. |
| Primary | Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 | 52 weeks | Laboratory toxicity grading was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 0 represents values in the normal range and grade 4 represents values with life-threatening consequences and urgent intervention indicated. |
| Primary | Number of Participants Who Developed Anti-etelcalcetide Antibodies | Baseline, Week 12, Week 24, Week 36, Week 53, the 30-day follow-up visit | A validated dual flow-cell biosensor immunoassay was used to detect antibodies capable of binding etelcalcetide. The number of participants with a negative or no result at baseline and positive binding antibodies at any time post-baseline is reported. |
| Primary | Change From Baseline in Blood Pressure | Baseline and Weeks 24 and 48 | Blood pressure (BP) values were taken post-hemodialysis assessments. |
| Secondary | Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase | Baseline and the efficacy assessment phase, defined as the last 6 weeks prior to ending treatment for participants who completed a minimum of 8 weeks of treatment (weeks 46-52 for participants who completed 52 weeks of treatment) | The efficacy assessment phase (EAP) is defined as the last 6 weeks before ending treatment, which was only for participants who completed a minimum of 8 weeks of treatment with etelcalcetide. If multiple assessments were available during the EAP, values were averaged. |
| Secondary | Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12 | Baseline and the efficacy assessment phase at month 12 (weeks 46-53) | The efficacy assessment phase at 12 months (EAP12) was defined as the period from week 46 to 53 (inclusive). If multiple assessments were available during the EAP12, values were averaged. |
| Secondary | Percentage of Participants With PTH ≤ 300 pg/mL During the EAP | Baseline and the efficacy assessment phase | |
| Secondary | Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12 | Week 46 to 53 | |
| Secondary | Percent Change From Baseline in Mean PTH During the EAP | Baseline and the efficacy assessment phase | |
| Secondary | Percent Change From Baseline in Mean PTH During the EAP12 | Baseline and the efficacy assessment phase at month 12 (weeks 46-53) | |
| Secondary | Percent Change From Baseline in Mean Corrected Calcium During the EAP | Baseline and the efficacy assessment phase | |
| Secondary | Percent Change From Baseline in Mean Corrected Calcium During the EAP12 | Baseline and the efficacy assessment phase at month 12 (weeks 46-53) | |
| Secondary | Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP | Baseline and the efficacy assessment phase | |
| Secondary | Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12 | Baseline and the efficacy assessment phase at month 12 (weeks 46-53) | |
| Secondary | Percent Change From Baseline in Mean Phosphorus During the EAP | Baseline and the efficacy assessment phase | |
| Secondary | Percent Change From Baseline in Mean Phosphorus During the EAP12 | Baseline and the efficacy assessment phase at month 12 (weeks 46-53) |
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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