Phase 3
N=891
Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis
Hyperparathyroidism, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT01785875 ↗Enrolled (actual)
891
Serious AEs
40.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 354; 337; 108; 799 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Etelcalcetide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
354; 337; 108; 799; 161; 142 | — |
| PRIMARY Number of Participants With Shift in Laboratory Values From Baseline Grade 0 or 1 to Post-baseline Grade 3 or 4 |
1; 9; 2; 3; 1; 51 | — |
| PRIMARY Number of Participants Who Developed Anti-etelcalcetide Antibodies |
10; 15; 2; 27 | — |
| PRIMARY Change From Baseline in Blood Pressure |
4.0; 4.5; -5.5; 2.9; 3.5; 6.5 | — |
| SECONDARY Percentage of Participants With > 30% Reduction From Baseline in PTH During the Efficacy Assessment Phase |
81.2; 54.5; 65.1; 67.7 | — |
| SECONDARY Percentage of Participants With > 30% Reduction From Baseline in PTH During the EAP12 |
82.5; 53.3; 63.5; 67.5 | — |
| SECONDARY Percentage of Participants With PTH ≤ 300 pg/mL During the EAP |
55.7; 59.7; 54.6; 57.3 | — |
| SECONDARY Percentage of Participants With PTH ≤ 300 pg/mL During the EAP12 |
54.8; 61.1; 42.7; 56.4 | — |
| SECONDARY Percent Change From Baseline in Mean PTH During the EAP |
-54.55; 3.92; -28.40; -26.07 | — |
| SECONDARY Percent Change From Baseline in Mean PTH During the EAP12 |
-55.41; 4.78; -27.05; -25.59 | — |
| SECONDARY Percent Change From Baseline in Mean Corrected Calcium During the EAP |
-10.01; -6.74; -8.65; -8.41 | — |
| SECONDARY Percent Change From Baseline in Mean Corrected Calcium During the EAP12 |
-9.76; -6.43; -9.73; -8.25 | — |
| SECONDARY Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP |
-15.26; -10.41; -6.58; -12.04 | — |
| SECONDARY Percent Change From Baseline in Mean Corrected Calcium Phosphorus Product During the EAP12 |
-15.30; -9.78; -7.29; -11.95 | — |
| SECONDARY Percent Change From Baseline in Mean Phosphorus During the EAP |
-5.71; -3.50; 2.82; -3.62 | — |
| SECONDARY Percent Change From Baseline in Mean Phosphorus During the EAP12 |
-5.87; -3.06; 3.53; -3.59 | — |
Summary
This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.
Eligibility Criteria
Inclusion Criteria
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject must complete the treatment and follow-up period, or have been discontinued for rising intact parathyroid hormone (iPTH), from an AMG 416 phase 3 parent study prior to the start of dosing in this study: 20120229 (NCT01785849), 20120230 (NCT01788046), or 20120359 (NCT01932970).
- Subject agrees to not participate in another study of an investigational agent during the study.
- Other Inclusion Criteria may apply
Exclusion Criteria
- Currently receiving treatment in another investigational device or drug study.
- Currently receiving other investigational procedures while participating in this study.
- Subject has known sensitivity to any of the products or components to be administered during dosing.
- Subject has an unstable medical condition based on medical history, physical examination, and routine laboratory tests, or is otherwise unstable in the judgment of the Investigator.
Other Exclusion Criteria may apply
Data sourced from ClinicalTrials.gov (NCT01785875). 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.