Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab

Amgen

Status and phase: Completed; Phase 1

Conditions: Mixed Dyslipidemia; Hyperlipidemia

Treatments: Biological: Evolocumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275156

20140213

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Evolocumab

Experimental group

Description:

Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.

Treatment:

Biological: Evolocumab