Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-02-03 @ 9:05 AM
Study NCT ID:
NCT02214693
Status:
COMPLETED
Last Update Posted:
2015-08-27
First Post:
2014-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557982', 'term': '4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2014-08-11', 'studyFirstSubmitQcDate': '2014-08-11', 'lastUpdatePostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve(AUC) last', 'timeFrame': 'Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['patients'], 'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 and 70\n* Weights between 50 and 90kg(Female : 40 and 90kg)\n* Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress\n* Stable results of estimated GFR in 4 months recently\n\nExclusion Criteria:\n\n* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)\n* Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction\n* Volunteer who already participated in other trials in 2 months\n* Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion'}, 'identificationModule': {'nctId': 'NCT02214693', 'briefTitle': 'PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients', 'orgStudyIdInfo': {'id': 'DA1229_RI_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1(Severe decrease in GFR)', 'description': 'Severe decrease in GFR', 'interventionNames': ['Drug: DA-1229']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2(Moderate decrease in GFR)', 'description': 'Moderate decrease in GFR', 'interventionNames': ['Drug: DA-1229']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3(Mild decrease in GFR)', 'description': 'Mild decrease in GFR', 'interventionNames': ['Drug: DA-1229']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4(Normal GFR)', 'description': 'Normal GFR', 'interventionNames': ['Drug: DA-1229']}], 'interventions': [{'name': 'DA-1229', 'type': 'DRUG', 'otherNames': ['Evogliptin'], 'armGroupLabels': ['Group 1(Severe decrease in GFR)', 'Group 2(Moderate decrease in GFR)', 'Group 3(Mild decrease in GFR)', 'Group 4(Normal GFR)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Clinical Trial Center, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}