A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
Study Details
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.
Protocol Summary
Maximum plasma concentration (Cmax) over the interdialytic interval following the first and last dose
Timeframe: Baseline to 55 days
Area under the plasma concentration-time curve (AUClast) over the interdialytic interval following the first and last dose
Timeframe: Baseline to 55 days
Incidence of adverse events
Timeframe: Baseline to 55 days
Number of participants with clinically-significant changes in vital signs
Timeframe: Baseline to 55 days
Number of participants with clinically-significant changes in electrocardiograms (ECGs)
Timeframe: Baseline to 55 days
Incidence of clinically-significant changes in laboratory safety tests including cCa (Calcium)
Timeframe: Baseline to 55 days
Subject incidence of anti-AMG 416 antibodies
Timeframe: Baseline to 55 days