Study Complete
Sponsor ID
20120360

Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet

Sponsor ID
20120360
Clinicaltrials.gov ID
NCT01896232
EUCTIS ID
N/A
EudraCT ID
2013-000192-33

Study Details

The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by > 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.

Additional Study Details

Phase
Phase 3
Product
AMG 416
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
683
Additional Study Details

Protocol Summary

Primary Outcome Measures

Reduction in mean pre-dialysis serum PTH level

Timeframe: Weeks 20-27

Secondary Outcome Measures

Reduction in mean pre-dialysis serum PTH

Timeframe: Weeks 20-27

Reduction in mean pre-dialysis serum PTH

Timeframe: Weeks 20-27

Frequency of nausea and vomiting

Timeframe: in the first 8 weeks

Change in mean pre-dialysis serum cCA

Timeframe: Weeks 20-27

Pre-dialysis serum phosphorus

Timeframe: Weeks 20-27

Severity of nausea

Timeframe: in the first 8 weeks

Vomiting

Timeframe: in the first 8 weeks

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Almada, Portugal, 2800-455
Status
Recruiting
Location
Research Site
Aveiro, Portugal, 3800-266
Status
Recruiting
Location
Research Site
Burlington, VT, United States, 05401
Status
Recruiting
Location
Research Site
Columbus, MS, United States, 39705
Status
Recruiting
Location
Research Site
Columbus, OH, United States, 43215
Status
Recruiting
Location
Research Site
Estoril, Portugal, 2765-294
Status
Recruiting
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