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

NCT02275156 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-11-07

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Evolocumab

Administered by subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-19
Primary Completion
2014-12-19
Completion
2014-12-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02275156 on ClinicalTrials.gov