Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
Subject is 18 years of age or older.
Subject agrees to not participate in another study of an investigational agent during the study.
Subject must be receiving hemodialysis 3 times weekly for at least 3 months
You may not be if
Currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(s) within 8 weeks prior to screening.
Other investigational procedures while participating in this study are excluded.
Anticipated or scheduled parathyroidectomy during the study period.
Subject has received a parathyroidectomy within 3 months prior to dosing.
Anticipated or scheduled kidney transplant during the study period.
Subject has known sensitivity to any of the products or components to be administered during dosing.
Subject has participated in a prior clinical trial of AMG 416
Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
Subject has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject.
Clareo Health | Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
