Phase 3 N=508 Randomized Triple-blind Treatment

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Hyperparathyroidism, Secondary

Bottom Line

View on ClinicalTrials.gov: NCT01785849 ↗

Enrolled (actual)

508

Serious AEs

28.9%

Results posted

Mar 2017

Primary outcome: Primary: Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase — 8.3; 74.0 percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Etelcalcetide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Amgen
Primary completion: May 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a > 30% Decrease From Baseline in Mean PTH During the Efficacy Assessment Phase	8.3; 74.0	<0.001 sig
SECONDARY Percentage of Participants With Mean Predialysis Parathyroid Hormone ≤ 300 pg/mL During the Efficacy Assessment Phase	5.1; 49.6	<0.001 sig
SECONDARY Percent Change From Baseline in Predialysis PTH During the Efficacy Assessment Phase	13.00; -55.11	<0.001 sig
SECONDARY Percent Change From Baseline in Predialysis Corrected Calcium During the Efficacy Assessment Phase	1.18; -7.29	<0.001 sig
SECONDARY Percent Change From Baseline in Predialysis Corrected Calcium Phosphorus Product During the Efficacy Assessment Phase	-0.19; -14.34	<0.001 sig
SECONDARY Percent Change From Baseline in Predialysis Phosphorus During the Efficacy Assessment Phase	-1.31; -7.71	0.003 sig

Summary

This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

Eligibility Criteria

Inclusion Criteria

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 must be receiving hemodialysis 3 times weekly for at least 3 months
Subject agrees to not participate in another study of an investigational agent during the study.
Other Inclusion Criteria may apply

Exclusion Criteria

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 (also referred to as KAI-4169).
Subject has received cinacalcet within the 4 weeks prior to screening labs (treatment with cinacalcet is prohibited during the study).
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.
Other Exclusion Criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01785849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.