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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-19

Study Completion Date

2014-12-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Hyperlipidemia Mixed Dyslipidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Evolocumab

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

Group Type EXPERIMENTAL

Evolocumab

Intervention Type BIOLOGICAL

Administered by subcutaneous injection

Interventions

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Evolocumab

Administered by subcutaneous injection

Intervention Type BIOLOGICAL

Other Intervention Names

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AMG 145 Repatha

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No