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Study Complete
Sponsor ID
20130213

Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Hemodialysis

Sponsor ID
20130213
Clinicaltrials.gov ID
NCT02102204
EUCTIS ID
N/A
EudraCT ID
2013-004136-30
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Study Details

This is a multicenter, single-arm, extension study to characterize the long-term safety and tolerability of etelcalcetide in the treatment of Secondary Hyperparathyroidism (SHPT) in adults with Chronic Kidney Disease (CKD) on hemodialysis.

Additional Study Details

Phase
Phase 3
Product
AMG 416
Type
Interventional
Masking
None (Open Label)
Enrollment
902
Additional Study Details

Protocol Summary

Primary Outcome Measures

Measure the subject incidence of adverse events reported

Timeframe: 2.5 Years

Secondary Outcome Measures

Measure the occurrence of iPTH value

Timeframe: months 6, 12, and 18

Measure the occurrence of Serum phosphorous (P)

Timeframe: months 6, 12, and 18

Assess the nature, frequency, severity, and relationship to treatment of all adverse events reported

Timeframe: 2.5 Years

Occurrence of cCa concentration < 7.5 mg/dL

Timeframe: months 6, 12, and 18

Assess vital signs, antibody formation to AMG 416, and changes in the laboratory parameters of albumin, total bilirubin (TBL), AST or ALT, and alkaline phosphatase

Timeframe: 2.5 Years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

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
Feldkirch, Austria, 6807
Status
Recruiting
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Study Info
Age
18 - 110 Years
Condition
  • Hyperparathyroidism
    • Sex
    All
    Trial Dates
    Mar 2014 - Nov 2016
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Subject has provided informed consent prior to initiation of any study-specific activities/procedures - Subject has completed treatment in Study 20120231 (also known as KAI-4169-008) or Study 20120360, or has participated in Study 20120334 (also known as KAI-4169-005-01) - Female subjects who are: post-menopausal (post-menopausal is defined as no menses for the previous 1 year and over the age of 50 years), surgically sterilized, have a medical condition that prevents pregnancy, remain abstinent, or are willing to use an acceptable method of effective contraception during the study and for 3 months after the last dose. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 2 weeks prior to the first dose of AMG 416 in the current study - Subject must be receiving hemodialysis 3 or 4 times weekly for at least 3 months
    Exclusion Criteria:
    - Currently receiving treatment in another investigational device or drug study (other than in one of the designated parent studies) - Subject has known sensitivity to any of the products or components to be administered during dosing - Subject has been prescribed cinacalcet by the primary nephrologist between the conclusion of the parent study and the start of dosing with AMG 416 in the current study - Subject is receiving dialysis prescription dialysate calcium concentration < 2.25 mEq/L - Subject is pregnant or nursing