Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-08 @ 10:20 PM
Study NCT ID:
NCT02480751
Status:
COMPLETED
Last Update Posted:
2015-06-29
First Post:
2015-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D009400', 'term': 'Nephrosclerosis'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C048081', 'term': 'beraprost'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'lastUpdateSubmitDate': '2015-06-26', 'studyFirstSubmitDate': '2015-06-21', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2015-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between the run-in and treatment periods in the slope of the regression line of 1/SCr versus time', 'timeFrame': '50 weeks (Run-in 22weeks, Treatment 28 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Renal Failure', 'Prostaglandin', 'Prostacyclin', 'Glomerular Disease; Nephrosclerosis'], 'conditions': ['Renal Insufficiency, Chronic']}, 'referencesModule': {'references': [{'pmid': '26475266', 'type': 'DERIVED', 'citation': 'Koyama A, Fujita T, Gejyo F, Origasa H, Isono M, Kurumatani H, Okada K, Kanoh H, Kiriyama T, Yamada S. Orally active prostacyclin analogue beraprost sodium in patients with chronic kidney disease: a randomized, double-blind, placebo-controlled, phase II dose finding trial. BMC Nephrol. 2015 Oct 16;16:165. doi: 10.1186/s12882-015-0130-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the recommended dose of the sustained-release form of BPS (TRK-100STP low dose or high dose) in Japanese patients with CRF (Primary glomerular disease/nephrosclerosis).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The CRF patient with primary glomerular disease or nephrosclerosis as the primary disease\n* The patient with progressive CRF\n\nExclusion Criteria:\n\n* The patient with secondary glomerular disease\n* The patient with CRF caused by pyelonephritis, interstitial/tubular nephritis, gouty kidney, polycystic kidney disease, or nephroureterolithiasis'}, 'identificationModule': {'nctId': 'NCT02480751', 'briefTitle': 'TRK-100STP PhaseII Clinical Study -Chronic Renal Failure (Primary Glomerular Disease/Nephrosclerosis)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Toray Industries, Inc'}, 'orgStudyIdInfo': {'id': '100CRS01/533-CL-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: Exprimental (TRK-100STP)', 'description': 'high dose', 'interventionNames': ['Drug: Beraprost']}, {'type': 'EXPERIMENTAL', 'label': '2: Exprimental (TRK-100STP)', 'description': 'low dose', 'interventionNames': ['Drug: Beraprost']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3: Placebo Comparator', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Beraprost', 'type': 'DRUG', 'armGroupLabels': ['1: Exprimental (TRK-100STP)', '2: Exprimental (TRK-100STP)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['3: Placebo Comparator']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Toray Industries, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}