CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Evolocumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02275156
NCT02275156Phase 1Completed
CompareCT.gov

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

Amgen·interventional·Posted Oct 27, 2014·Updated Nov 7, 2022

In Brief

A Phase 1 clinical trial evaluating Evolocumab for Hyperlipidemia and Mixed Dyslipidemia. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyperlipidemia, Mixed Dyslipidemia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 27, 2014
Enrollment StartAug 19, 2014
Primary CompletionDec 19, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.7 years ago

Interventions

Evolocumabbiological

Administered by subcutaneous injection