Phase 1
N=18
Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
Hyperlipidemia · Mixed Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT02275156 ↗Enrolled (actual)
18
Serious AEs
5.6%
Results posted
Jan 2016
Primary outcome: Primary: Maximum Observed Serum Concentration (Cmax) of Evolocumab — 21.3; 15.1; 11.7 μg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Evolocumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Serum Concentration (Cmax) of Evolocumab |
21.3; 15.1; 11.7 | — |
| PRIMARY Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) for Evolocumab |
185; 141; 102 | — |
| SECONDARY Number of Participants With Adverse Events |
1; 1; 2; 1; 1; 0 | — |
| SECONDARY Number of Participants With Clinically Relevant Vital Sign or Clinical Laboratory Changes |
0; 0; 0 | — |
| SECONDARY Number of Participants With Anti-evolocumab Antibodies |
0; 0; 0 | — |
| SECONDARY Area Under the Effect Curve From Baseline to Day 57 (AUECday1-57) for Low-density Lipoprotein Cholesterol (LDL-C) |
4438.6; 4087.5; 4620.2 | — |
| SECONDARY Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) |
-91.69; -79.20; -72.95; -96.67; -95.87; -94.41 | — |
Summary
The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis.
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m² at screening.
- Subjects will have low-density lipoprotein cholesterol (LDL-C) of 70-190 mg/dL (inclusive) and on statin therapy.
- Other inclusion criteria may apply.
Exclusion Criteria
- Subject with current or prior history of statin intolerance
- Subject has previously received Evolocumab (AMG 145) or any other investigational therapy directed against PCSK9
- Known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1
- Testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1 (alcohol only)
- History of hypersensitivity or allergic reaction to mammalian-derived drug preparations
- Known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose
- Other exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02275156). 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.