Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-23 @ 6:29 AM
Study NCT ID:
NCT00556257
Status:
WITHDRAWN
Last Update Posted:
2008-05-30
First Post:
2007-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'lastUpdateSubmitDate': '2008-05-27', 'studyFirstSubmitDate': '2007-11-08', 'studyFirstSubmitQcDate': '2007-11-08', 'lastUpdatePostDateStruct': {'date': '2008-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical biopsy proven acute rejection rate at 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics of CP-690,550', 'timeFrame': '12 months'}, {'measure': 'Lymphocyte subsets', 'timeFrame': '12 months'}, {'measure': 'Posttransplant humoral alloreactivity', 'timeFrame': '12 months'}, {'measure': 'Safety and tolerability of CP-690,550', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Immunosuppression, JAK3 inhibitor, kidney transplantation'], 'conditions': ['Kidney Transplantation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921037&StudyName=Study%20Of%20JAK3%20Inhibitor%20For%20The%20Prevention%20Of%20Acute%20Rejection%20In%20Kidney%20Transplant%20Patients', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A new immunosuppressive drug based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months in addition to other standard transplant medications such as prednisone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient of first time kidney transplant\n* Between the ages of 18 and 70 years, inclusive\n\nExclusion Criteria:\n\n* Recipient of any non-kidney transplant'}, 'identificationModule': {'nctId': 'NCT00556257', 'briefTitle': 'Study Of JAK3 Inhibitor For The Prevention Of Acute Rejection In Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Pilot Randomized, Multicenter, Open-Label, Active Comparator-Controlled Trial Of A CP-690,550-Based Regimen In De Novo Kidney Allograft Recipients', 'orgStudyIdInfo': {'id': 'A3921037'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm 1', 'description': 'Treatment Arm 1 will also receive standard of care medications.', 'interventionNames': ['Drug: Cyclosporine']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 2', 'description': 'Treatment Arm 2 will also receive select standard of care medications.', 'interventionNames': ['Drug: CP-690-,550']}], 'interventions': [{'name': 'Cyclosporine', 'type': 'DRUG', 'description': 'Standard of care', 'armGroupLabels': ['Treatment Arm 1']}, {'name': 'CP-690-,550', 'type': 'DRUG', 'description': 'CP-690550 20 mg BID in Months 1-6 then 15 mg BID in Months 7-12', 'armGroupLabels': ['Treatment Arm 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer'}}}}