Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-31 @ 9:02 AM
Study NCT ID:
NCT00098735
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2004-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Germany', 'Ireland', 'Netherlands', 'Poland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012059', 'term': 'Rejection, Psychology'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068876', 'term': 'Fingolimod Hydrochloride'}], 'ancestors': [{'id': 'D013110', 'term': 'Sphingosine'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011409', 'term': 'Propylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-16', 'studyFirstSubmitDate': '2004-12-07', 'studyFirstSubmitQcDate': '2004-12-07', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant'}, {'measure': 'Permanent resumption of dialysis within 6 months post transplant'}, {'measure': 'Surgical removal of graft within 6 months post transplant'}, {'measure': 'Death within 6 months post transplant'}, {'measure': 'Withdrawal of consent, death, or lost to follow up within 6 months post transplant'}], 'secondaryOutcomes': [{'measure': 'IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant'}, {'measure': 'Permanent resumption of dialysis within 12 months post transplant'}, {'measure': 'Surgical removal of graft within 12 months post transplant'}, {'measure': 'Death within 12 months post transplant'}, {'measure': 'Withdrawal of consent, death, or lost to follow up within 12 months post transplant'}, {'measure': 'Serum creatinine, estimated creatinine clearance, abnormalities of vital signs and laboratory variables and measurements of urine protein at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.'}, {'measure': 'FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12'}, {'measure': 'Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.'}]}, 'conditionsModule': {'keywords': ['Kidney,Transplantation, rejection, immunosuppression'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '15940045', 'type': 'RESULT', 'citation': 'Tedesco-Silva H, Mourad G, Kahan BD, Boira JG, Weimar W, Mulgaonkar S, Nashan B, Madsen S, Charpentier B, Pellet P, Vanrenterghem Y. FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. Transplantation. 2005 Jun 15;79(11):1553-60.'}]}, 'descriptionModule': {'briefSummary': 'In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First kidney transplantation\n* Male and female patients\n* Between 18 and 65 years old\n\nExclusion Criteria:\n\n* Patient in need of multi-organ transplant\n* Patients with history of cardiac arrest\n* Patients with any past or present malignancy'}, 'identificationModule': {'nctId': 'NCT00098735', 'briefTitle': 'Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation', 'orgStudyIdInfo': {'id': 'CFTY720A2302'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FTY720', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'NOVARTIS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}