Secondary Hyperparathyroidism in Patients With ESRD on Hemodialysis Clinical Trial
Official title:
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Biotransformation and Excretion of [¹⁴C]AMG 416 in Patients With End Stage Renal Disease Receiving Dialysis
The primary objectives of this study were to determine the rate, extent, and routes of radioactivity excretion of [¹⁴C]etelcalcetide in feces, dialysate, and urine over time and to measure radioactivity concentrations in whole blood and plasma over time.
Six adult male or female patients with end stage renal disease requiring hemodialysis will be
enrolled to receive 750 nCi of [¹⁴C]-labeled etelcalcetide formulated in 10 mg etelcalcetide
administered as a single 2 mL intravenous dose at the end of hemodialysis.
Participants will spend the first approximately 12 days in confinement at the clinic (day -1
until completion of day 11 study procedures). Blood samples, and complete collections of
dialysate, dialysis membrane (as necessary), urine (as available), and feces will be analyzed
for radioactivity content by accelerator mass spectrometry (AMS). Following the confinement
period, participants will return to the site on an outpatient basis in accordance to their
routine dialysis sessions up to day 39. Blood and dialysate samples and dialysis membranes
will be collected at specified times during the outpatient visit period.
Participants may be asked to return so the site for the Extended Pharmacokinetic Collection
Period. During the Extended Pharmacokinetic Collection Period, participants will return to
the site for 3 consecutive hemodialysis sessions (Collection Period 1) and then again
approximately one month later, for an additional 3 consecutive hemodialysis sessions
(Collection Period 2).
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