Phase 3
N=902
Extension Study of Etelcalcetide for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis
Hyperparathyroidism, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT02102204 ↗Enrolled (actual)
902
Serious AEs
49.3%
Results posted
Nov 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 768; 436; 287; 4 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
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
768; 436; 287; 4; 41; 89 | — |
| SECONDARY Percentage of Participants With Parathyroid Hormone Levels Between Two to Nine-times the Upper Limit of Normal |
67.0; 73.2; 71.9 | — |
| SECONDARY Percentage of Participants With Serum Phosphorus ≤ the ULN |
39.4; 40.0; 36.8 | — |
| SECONDARY Percentage of Participants With Serum Corrected Calcium < 7.5 mg/dL |
9.5; 14.1; 16.3 | — |
| SECONDARY Number of Participants With Shifts From Baseline Grade 0 or 1 to Postbaseline Grade 3 or 4 for Laboratory Parameters |
1; 2; 1; 18; 2; 1 | — |
| SECONDARY Number of Participants Who Developed Positive Binding Anti-Etelcalcetide Antibodies |
111 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02102204). 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.