Study Complete
Sponsor ID
20140197

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

Sponsor ID
20140197
Clinicaltrials.gov ID
NCT03283098
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
etelcalcetide
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
33
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Shanghai, Shanghai, China, 200040
Status
Recruiting
Location
Research Site
Shanghai, Shanghai, China, 200032
Status
Recruiting
Location
Research Site
Shanghai, Shanghai, China, 200127
Status
Recruiting
Location
Research Site
Nanjing, Jiangsu, China, 210029
Status
Recruiting
Location
Research Site
Beijing, Beijing, China, 100044
Status
Recruiting