Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 1:49 AM
Study NCT ID:
NCT02427035
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584257', 'term': 'CSL112'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-18', 'studyFirstSubmitDate': '2015-04-20', 'studyFirstSubmitQcDate': '2015-04-24', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma apolipoprotein A-I (apoA-I) and phosphatidylcholine (PC) area under the curve (AUC)', 'timeFrame': 'Before and at up to 10 time points (during up to 7 days) after infusion', 'description': 'Baseline corrected plasma apoA-I and PC AUC0-infinity'}, {'measure': 'Plasma apoA-I and PC AUC0-last and AUC 0-t', 'timeFrame': 'Before and at up to 10 time points (during up to 7 days) after infusion', 'description': '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'}, {'measure': 'Plasma apoA-I and PC Cmax', 'timeFrame': 'Before and at up to 10 time points (during up to 7 days) after infusion'}, {'measure': 'Plasma apoA-I and PC Tmax', 'timeFrame': 'Before and at up to 10 time points (during up to 7 days) after infusion'}, {'measure': 'Plasma apoA-I and PC Volume of distribution during terminal phase', 'timeFrame': 'Before and at up to 10 time points (during up to 7 days) after infusion'}, {'measure': 'Plasma apoA-I and PC clearance', 'timeFrame': 'Before and at up to 10 time points (during up to 7 days) after infusion'}, {'measure': 'Plasma apoA-I and PC t1/2', 'timeFrame': 'Before and at up to 10 time points (during up to 7 days) after infusion'}, {'measure': 'Urinary excretion of apoA-I (Ae0-t)', 'timeFrame': 'Before and up to 48 hours after infusion', 'description': 'Amount excreted (Ae) of apoA-I over a collection interval 0-t.'}, {'measure': 'Urinary excretion of apoA-I (%fe0-t)', 'timeFrame': 'Before and up to 48 hours after infusion', 'description': 'Percent fraction excreted (%fe) of apoA-I in urine over time interval 0-t, calculated as Ae0-t/Dose x 100.'}, {'measure': 'Renal clearance of apoA-I', 'timeFrame': 'Before and up to 48 hours after infusion', 'description': 'Renal clearance of apoA-I, calculated as Ae0-48/AUC0-48'}], 'secondaryOutcomes': [{'measure': 'Urinary excretion of sucrose(Ae0-t)', 'timeFrame': 'Before and up to 48 hours after infusion', 'description': 'Amount of sucrose excreted over a collection interval 0-t.'}, {'measure': 'Urinary excretion of sucrose (%fe0-t)', 'timeFrame': 'Before and up to 48 hours after infusion', 'description': 'Percent fraction excreted sucrose in urine over time interval 0-t, calculated as Ae0-t/Dose x 100.'}, {'measure': 'Urinary excretion of sucrose (clearance)', 'timeFrame': 'Before and up to 48 hours after infusion', 'description': 'Renal clearance of sucrose, calculated as Ae0-48/AUC0-48'}, {'measure': 'Adverse drug reaction (ADR) or suspected ADR frequency (%)', 'timeFrame': 'Up to approximately 127 days', 'description': "The overall percentage of participants with adverse reactions or suspected adverse reactions:\n\n1. That begin during or within 1 hour of an infusion; or\n2. That may be causally related to the administration of the investigational product; or\n3. For which the Investigator's causality assessment is missing or indeterminate; or\n4. 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."}, {'measure': 'Clinically significant changes in routine safety assessments', 'timeFrame': 'Up to approximately 97 days', 'description': '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.'}, {'measure': 'Clinically important change in drug-induced liver injury', 'timeFrame': 'From baseline (before infusion) up to Day 16.', 'description': '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.'}, {'measure': 'Clinically important change in renal status', 'timeFrame': 'From baseline (before infusion) up to Day 16.', 'description': '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.'}, {'measure': 'Plasma sucrose AUC', 'timeFrame': 'Before and at up to 7 time points (during up to 2 days) after infusion', 'description': 'Baseline corrected plasma sucrose AUC0-infinity'}, {'measure': 'Plasma sucrose AUC0-last and AUC 0-t', 'timeFrame': 'Before and at up to 7 time points (during up to 2 days) after infusion', 'description': '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'}, {'measure': 'Plasma sucrose Cmax', 'timeFrame': 'Before and at up to 7 time points (during up to 2 days) after infusion'}, {'measure': 'Plasma sucrose Tmax', 'timeFrame': 'Before and at up to 7 time points (during up to 2 days) after infusion'}, {'measure': 'Plasma sucrose Volume of distribution during terminal phase', 'timeFrame': 'Before and at up to 7 time points (during up to 2 days) after infusion'}, {'measure': 'Plasma sucrose Clearance', 'timeFrame': 'Before and at up to 7 time points (during up to 2 days) after infusion'}, {'measure': 'Plasma sucrose t1/2', 'timeFrame': 'Before and at up to 7 time points (during up to 2 days) after infusion'}, {'measure': 'Adverse drug reaction (ADR) or suspected ADR frequency', 'timeFrame': 'Up to approximately 127 days', 'description': "The overall number of participants with adverse reactions or suspected adverse reactions:\n\n1. That begin during or within 1 hour of an infusion; or\n2. That may be causally related to the administration of the investigational product; or\n3. For which the Investigator's causality assessment is missing or indeterminate; or\n4. 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."}, {'measure': 'Number of subjects with AEs', 'timeFrame': 'After the start of infusion up to approximately 127 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '33217027', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30240132', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 18 to 85 years (inclusive) of age, with body weight 50 kg or more.\n* Subjects with renal impairment (RI) must have stable chronic moderate RI (estimated glomerular filtration rate \\[eGFR\\] ≥ 30 and \\< 60 mL/min/1.73 m2)\n* Healthy subjects must have normal renal function (eGFR ≥ 90 mL/min/1.73 m2)\n\nExclusion Criteria:\n\n* Evidence of a clinically significant medical condition, disorder or disease\n* Evidence of hepatobiliary disease\n* Any clinically relevant abnormal laboratory test result\n* Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components\n* 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\n* Evidence or history of alcohol or substance abuse'}, 'identificationModule': {'nctId': 'NCT02427035', 'briefTitle': 'A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CSL112_1001'}, 'secondaryIdInfos': [{'id': '2014-005520-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low', 'description': '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.', 'interventionNames': ['Biological: CSL112', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'High', 'description': '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.', 'interventionNames': ['Biological: CSL112', 'Other: Placebo']}], 'interventions': [{'name': 'CSL112', 'type': 'BIOLOGICAL', 'description': 'CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.', 'armGroupLabels': ['High', 'Low']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0.9% weight/volume sodium chloride solution (ie, normal saline)', 'armGroupLabels': ['High', 'Low']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Study Site - 17101', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-81241', 'city': 'Munich', 'country': 'Germany', 'facility': 'Study Site - 17102', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'SE1 1YR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Study Site - 24101', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Study Site - 24102', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': "Denise D'Andrea, M.D.", 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}