Status:
COMPLETED
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Lead Sponsor:
Amgen
Conditions:
Secondary Hyperparathyroidism
Chronic Kidney Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments
- Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value \> 500 pg/mL, measured on separate days within 2 weeks prior to randomization
- Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization
- Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization
Exclusion
- Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
- Other criteria may apply
Key Trial Info
Start Date :
August 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2015
Estimated Enrollment :
683 Patients enrolled
Trial Details
Trial ID
NCT01896232
Start Date
August 13 2013
End Date
January 8 2015
Last Update
July 18 2019
Active Locations (182)
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1
Research Site
Azusa, California, United States, 91702
2
Research Site
Bakersfield, California, United States, 93306
3
Research Site
Bakersfield, California, United States, 93309
4
Research Site
Chula Vista, California, United States, 91910