The purpose of this study is to evaluate the effect of thrice weekly intravenous (IV) administration of etelcalcetide in the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients with chronic kidney disease-mineral and bone disorder (CKD-MBD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
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.
Time frame: 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 ≥ 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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)