Phase 3
Completed N=683
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Source: ClinicalTrials.gov NCT01896232 ↗Enrolled (actual)
683
Serious AEs
26.2%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis — 63.9; 77.9 percentage of participants
◆ Published Evidence
Highly cited
302citations · ~34 / year
Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial.
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 baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.
Linked Publications
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Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis |
63.9; 77.9 | — |
| SECONDARY Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase |
40.2; 52.4 | 0.001 sig |
| SECONDARY Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase |
57.7; 68.2 | 0.004 sig |
| SECONDARY Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks |
0.3; 0.4 | 0.27 |
| SECONDARY Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase |
-6.28; -9.83 | — |
| SECONDARY Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase |
29.2; 32.1 | — |
| SECONDARY Mean Severity of Nausea in the First 8 Weeks |
0.48; 0.45 | — |
| SECONDARY Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks |
0.1; 0.2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment
- Other criteria may apply
Data sourced from ClinicalTrials.gov (NCT01896232) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.