NCT03283098

A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Secondary Hyperparathyroidism

Interventions

Type	Name	Description
DRUG	Etelcalcetide	Etelcalcetide was supplied as a sterile, preservative-free, aqueous solution in a single-use 3 mL glass vial.
DRUG	Placebo	Placebo supplied to match active intervention.

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2017-09-14
• Last updated: 2020-02-10
• Results posted: 2020-02-10

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated drug study