A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment
NCT ID: NCT02427035
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2015-05-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low
A low dose of either CSL112 or placebo is to be administered as a single intravenous (IV) infusion. The placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.
CSL112
CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
Placebo
0.9% weight/volume sodium chloride solution (ie, normal saline)
High
A high dose of either CSL112 or placebo is to be administered as a single intravenous (IV) infusion. The placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.
CSL112
CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
Placebo
0.9% weight/volume sodium chloride solution (ie, normal saline)
Interventions
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CSL112
CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
Placebo
0.9% weight/volume sodium chloride solution (ie, normal saline)
Eligibility Criteria
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Inclusion Criteria
* Subjects with renal impairment (RI) must have stable chronic moderate RI (estimated glomerular filtration rate \[eGFR\] ≥ 30 and \< 60 mL/min/1.73 m2)
* Healthy subjects must have normal renal function (eGFR ≥ 90 mL/min/1.73 m2)
Exclusion Criteria
* Evidence of hepatobiliary disease
* Any clinically relevant abnormal laboratory test result
* Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
* Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study, including: history of cancer, low platelet count, bleeding disorder or coagulopathy, significantly altered electrocardiogram waveform, unstable glycemia control in subjects with diabetes, acute renal failure, recent donation or loss of blood
* Evidence or history of alcohol or substance abuse
18 Years
85 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Denise D'Andrea, M.D.
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Study Site - 17101
Berlin, , Germany
Study Site - 17102
Munich, , Germany
Study Site - 24101
London, , United Kingdom
Study Site - 24102
Manchester, , United Kingdom
Countries
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References
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Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.
Tortorici MA, Duffy D, Evans R, Feaster J, Gille A, Mant TGK, Wright SD, D'Andrea D. Pharmacokinetics and Safety of CSL112 (Apolipoprotein A-I [Human]) in Adults With Moderate Renal Impairment and Normal Renal Function. Clin Pharmacol Drug Dev. 2019 Jul;8(5):628-636. doi: 10.1002/cpdd.618. Epub 2018 Sep 21.
Other Identifiers
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2014-005520-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSL112_1001
Identifier Type: -
Identifier Source: org_study_id