Secondary Hyperparathyroidism Clinical Trial
Official title:
A Phase 1, Multiple Dose, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pharmacokinetics, Safety and Tolerability of AMG 416 Administered Intravenously to Chinese Subjects With Chronic Kidney Disease on Hemodialysis
This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese
subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis
were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3
times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of
approximately 4 weeks.
Doses were given at the end of each scheduled hemodialysis session on study days 1 through
day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were
performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.
n/a
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