Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 12/1/2018 |
| Start Date: | August 19, 2014 |
| End Date: | December 19, 2014 |
Phase 1, Open-label, Single-dose Study of Evolocumab (AMG 145) Administered Subcutaneously to Subjects With Normal Renal Function or Severe Renal Impairment or End Stage Renal Disease Receiving Hemodialysis
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.
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.
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.
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