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Clinical Trial Details

Trial ID: L1723
Source ID: NCT01576146
Associated Drug: Etelcalcetide
Title: Open-label Study to Assess the Long-term Safety and Efficacy of Etelcalcetide (Also Known as AMG 416 or KAI-4169) in Patients With Secondary Hyperparathyroidism
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01576146/results
Conditions: Secondary Hyperparathyroidism
Interventions: DRUG: Etelcalcetide
Outcome Measures: Primary: Number of Participants With Adverse Events, From the first dose of study drug in the parent study (20120331) through 30 days after the last dose in the extension study; actual median duration of treatment was 439 days. | Secondary: Percent Change From Baseline in Parathyroid Hormone, Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of etelcalcetide in the parent study (20120331). The week numbering for this study continued from the parent study 20120331 hence the first measurement for all parameters in the extension study started at week 13., Baseline (of the parent study 20120331) and Weeks 13, 26 and 52|Percent Change From Baseline in Serum Corrected Calcium, Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13., Baseline and Weeks 13, 26 and 52|Percent Change From Baseline in Serum Phosphorus, Baseline was defined as the average of 3 predialysis results obtained within 3 weeks before the first dose of study drug in the parent study (20120331). The week numbering for this study continued from the parent study 20120331; the first measurement for all parameters in the extension study started at week 13., Baseline and Weeks 13, 26 and 52
Sponsor/Collaborators: Sponsor: KAI Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2012-03
Completion Date: 2014-05-01
Results First Posted: 2017-04-13
Last Update Posted: 2017-04-13
Locations:
URL: https://clinicaltrials.gov/show/NCT01576146