Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1510
Source ID: NCT01414114
Associated Drug: Etelcalcetide
Title: Etelcalcetide to Treat Secondary Hyperparathyroidism in Hemodialysis Patients With Chronic Kidney Disease-Mineral and Bone Disorder
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01414114/results
Conditions: Secondary Hyperparathyroidism
Interventions: DRUG: Etelcalcetide
Outcome Measures: Primary: Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Period, Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period., Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment) | Secondary: Percentage of Participants With ≥ 30% Reduction in PTH From Baseline During the Efficacy Period, The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period., Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Percentage of Participants With PTH ≤ 300 pg/mL During the Efficacy Period, The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period., The efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Percent Change From Baseline in Corrected Calcium During the Efficacy Period, Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period., Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)|Percent Change From Baseline in Phosphorus During the Efficacy Period, Baseline was defined as the average of 3 predialysis PTH results obtained within 3 weeks of and prior to the first dose of study drug. The efficacy period (defined as the period from 14 days prior to and 3 days after the last dose of study drug) value was the mean of the prehemodialysis values obtained during that period., Baseline and the efficacy period, defined as from 14 days prior to and 3 days after the last dose of study drug (approximately days 68 - 85 for participants who completed 12 weeks of treatment)
Sponsor/Collaborators: Sponsor: KAI Pharmaceuticals
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 37
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2011-12-05
Completion Date: 2012-05-21
Results First Posted: 2017-04-11
Last Update Posted: 2017-04-11
Locations:
URL: https://clinicaltrials.gov/show/NCT01414114