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Study Complete
Sponsor ID
20140213

Estimation study to assess the effect of severe renal impairment and end-stage renal disease hemodialysis on the pharmacokinetics of evolocumab

Sponsor ID
20140213
Clinicaltrials.gov ID
NCT02275156
EUCTIS ID
N/A
EudraCT ID
N/A
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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.

Additional Study Details

Phase
Phase 1
Product
Evolocumab
Type
Interventional
Masking
None (Open Label)
Enrollment
18
Additional Study Details

Protocol Summary

Primary Outcome Measures

Evolocumab (AMG 145) PK parameter - maximum serum concentration [Cmax]

Timeframe: 8 Weeks

Evolocumab (AMG 145) PK parameters - area under the serum concentration-time curve [AUC]

Timeframe: 8 Weeks

Secondary Outcome Measures

Treatment emergent adverse events

Timeframe: 8 Weeks

Vital signs

Timeframe: 8 Weeks

Presence of anti-Evolocumab (AMG 145) antibodies

Timeframe: 8 Weeks

Area under the effect curve from baseline to day 57 (AUECday1-day57) for LDL-C

Timeframe: 8 Weeks

Serum levels of PCSK9

Timeframe: 8 Weeks

Labortory safety tests

Timeframe: 8 Weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
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Location
Research Site
Denver, CO, United States, 80230
Status
Recruiting
Study Info
Age
18 - 70 Years
Condition
  • Cholesterol
    • Sex
    All
    Trial Dates
    Aug 2014 - Dec 2014
    Inclusion and Exclusion Criteria
    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.