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Completed

NCT Number: NCT02427035

A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment

This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult subjects with moderate renal impairment and in healthy adult subjects with normal renal function.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Study Site - 17101, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women aged 18 to 85 years (inclusive) of age, with body weight 50 kg or more.
  • 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 a clinically significant medical condition, disorder or disease
  • 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

Treatment and study plan

CSL112

Biological

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

Other

0.9% weight/volume sodium chloride solution (ie, normal saline)

Primary outcomes

  1. Plasma apolipoprotein A-I (apoA-I) and phosphatidylcholine (PC) area under the curve (AUC)

    Time frame: Before and at up to 10 time points (during up to 7 days) after infusion

    Baseline corrected plasma apoA-I and PC AUC0-infinity

  2. Plasma apoA-I and PC AUC0-last and AUC 0-t

    Time frame: Before and at up to 10 time points (during up to 7 days) after infusion

    AUC from time point zero to the last quantifiable time point before the analyte first returns to baseline (AUC0-last) and/or a partial AUC from baseline to time point t (AUC0-t) with and without baseline correction

  3. Plasma apoA-I and PC Cmax

    Time frame: Before and at up to 10 time points (during up to 7 days) after infusion

  4. Plasma apoA-I and PC Tmax

    Time frame: Before and at up to 10 time points (during up to 7 days) after infusion

  5. Plasma apoA-I and PC Volume of distribution during terminal phase

    Time frame: Before and at up to 10 time points (during up to 7 days) after infusion

  6. Plasma apoA-I and PC clearance

    Time frame: Before and at up to 10 time points (during up to 7 days) after infusion

  7. Plasma apoA-I and PC t1/2

    Time frame: Before and at up to 10 time points (during up to 7 days) after infusion

  8. Urinary excretion of apoA-I (Ae0-t)

    Time frame: Before and up to 48 hours after infusion

    Amount excreted (Ae) of apoA-I over a collection interval 0-t.

  9. Urinary excretion of apoA-I (%fe0-t)

    Time frame: Before and up to 48 hours after infusion

    Percent fraction excreted (%fe) of apoA-I in urine over time interval 0-t, calculated as Ae0-t/Dose x 100.

  10. Renal clearance of apoA-I

    Time frame: Before and up to 48 hours after infusion

    Renal clearance of apoA-I, calculated as Ae0-48/AUC0-48

Secondary outcomes

  1. Urinary excretion of sucrose(Ae0-t)

    Time frame: Before and up to 48 hours after infusion

    Amount of sucrose excreted over a collection interval 0-t.

  2. Urinary excretion of sucrose (%fe0-t)

    Time frame: Before and up to 48 hours after infusion

    Percent fraction excreted sucrose in urine over time interval 0-t, calculated as Ae0-t/Dose x 100.

  3. Urinary excretion of sucrose (clearance)

    Time frame: Before and up to 48 hours after infusion

    Renal clearance of sucrose, calculated as Ae0-48/AUC0-48

  4. Adverse drug reaction (ADR) or suspected ADR frequency (%)

    Time frame: Up to approximately 127 days

    The overall percentage of participants with adverse reactions or suspected adverse reactions:

    • That begin during or within 1 hour of an infusion; or
    • That may be causally related to the administration of the investigational product; or
    • For which the Investigator's causality assessment is missing or indeterminate; or
    • For which the incidence in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.

  5. Clinically significant changes in routine safety assessments

    Time frame: Up to approximately 97 days

    The number of participants with clinically significant changes in any of the following assessments: clinical laboratory tests, physical examinations, body weight, electrocardiograms, vital signs, immunogenicity testing, serology, nucleic acid testing or proteinuria findings.

  6. Clinically important change in drug-induced liver injury

    Time frame: From baseline (before infusion) up to Day 16.

    A clinically important change in drug-induced liver injury is defined as a change (from baseline) in alanine aminotransferase (ALT) greater than 3 times the upper limit of normal (ULN) or a change in total bilirubin greater than 2 times ULN, that is confirmed upon repeat measurement.

  7. Clinically important change in renal status

    Time frame: From baseline (before infusion) up to Day 16.

    A clinically important change in renal status is defined as a serum creatinine (Cr) increase to ≥ 1.5 x the baseline value that is confirmed upon repeat measurement, or the need for renal replacement therapy.

  8. Plasma sucrose AUC

    Time frame: Before and at up to 7 time points (during up to 2 days) after infusion

    Baseline corrected plasma sucrose AUC0-infinity

  9. Plasma sucrose AUC0-last and AUC 0-t

    Time frame: Before and at up to 7 time points (during up to 2 days) after infusion

    AUC from time point zero to the last quantifiable time point before the analyte first returns to baseline (AUC0-last) and/or a partial AUC from baseline to time point y (AUC0-t) with and without baseline correction

  10. Plasma sucrose Cmax

    Time frame: Before and at up to 7 time points (during up to 2 days) after infusion

  11. Plasma sucrose Tmax

    Time frame: Before and at up to 7 time points (during up to 2 days) after infusion

  12. Plasma sucrose Volume of distribution during terminal phase

    Time frame: Before and at up to 7 time points (during up to 2 days) after infusion

  13. Plasma sucrose Clearance

    Time frame: Before and at up to 7 time points (during up to 2 days) after infusion

  14. Plasma sucrose t1/2

    Time frame: Before and at up to 7 time points (during up to 2 days) after infusion

  15. Adverse drug reaction (ADR) or suspected ADR frequency

    Time frame: Up to approximately 127 days

    The overall number of participants with adverse reactions or suspected adverse reactions:

    • That begin during or within 1 hour of an infusion; or
    • That may be causally related to the administration of the investigational product; or
    • For which the Investigator's causality assessment is missing or indeterminate; or
    • For which the incidence in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.

  16. Number of subjects with AEs

    Time frame: After the start of infusion up to approximately 127 days

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled, Pharmacokinetic, Safety and Tolerability Study of CSL112 in Adult Subjects With Moderate Renal Impairment and in Healthy Adult Subjects With Normal Renal Function

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 27, 2015
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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