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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Amgen
Study ID
NCT02275156
Phase
PHASE1
Status
Completed

Conditions

  • Hyperlipidemia
  • Mixed Dyslipidemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — BIOLOGICAL
    Administered by subcutaneous injection

Study Details

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.

Key Dates

Start date
Aug 19, 2014
Status verified
Nov 2022
Primary completion
Dec 19, 2014
Completion
Dec 19, 2014

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of Evolocumab [ Time Frame: Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteDenverColorado80230-

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Research Site· Denver, CO

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