Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00189735
Status:
COMPLETED
Last Update Posted:
2008-04-17
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate FK778 in Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
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'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of biopsy-proven acute rejection over the first 24 weeks.'}], 'secondaryOutcomes': [{'measure': 'Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year'}, {'measure': 'Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year'}, {'measure': 'Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year'}, {'measure': 'Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year'}, {'measure': 'Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year'}, {'measure': 'Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year'}, {'measure': 'Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.'}, {'measure': 'Safety first 24 weeks: Patient survival'}, {'measure': 'Graft survival'}, {'measure': 'Incidence of adverse events'}, {'measure': 'Routine safety laboratory parameters'}, {'measure': 'Haemoglobin values at weeks two to six'}, {'measure': 'Leukocytes at weeks two to six'}, {'measure': 'Thrombocytes at weeks two to six'}, {'measure': 'Bilirubin at weeks two to six'}, {'measure': 'Incidence of CMV viraemia'}, {'measure': 'Incidence of Diarrhoea, Gastroenteritis and Gastritis'}, {'measure': 'Safety after 1 year:Incidence of adverse events'}, {'measure': 'Patient and graft survival'}]}, 'conditionsModule': {'keywords': ['Treatment Efficacy', 'Treatment Effectiveness', 'Anti-rejection therapy', 'Immunosuppression', 'Antirejection', 'Malononitrilamide'], 'conditions': ['Kidney Transplantation', 'Renal Transplantation', 'Transplantation, Renal', 'Transplantation, Kidney', 'Grafting, Kidney']}, 'descriptionModule': {'briefSummary': 'A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).\n* Patient has been fully informed.\n\nExclusion Criteria:\n\n* Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.\n* Patient has significant liver disease.\n* Cold ischemia time of the donor kidney \\>28 hours.\n* Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.\n* Patient has previously received or is receiving an organ transplant other than kidney.'}, 'identificationModule': {'nctId': 'NCT00189735', 'briefTitle': 'A Study to Evaluate FK778 in Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients', 'orgStudyIdInfo': {'id': 'FG-778-02-60'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FK778', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 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H. Neumayer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinik Charité'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}]}}}