[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601102":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":25,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":81,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug","EXPERIMENTAL","TMP-SMX",[13],"Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)",{"label":15,"type":16,"description":15,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Usual Care",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Trimethoprim-Sulfamethoxazole (TMP-SMX)","Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care","Participants will take a placebo from months 6-12 after transplant and continue to receive all standard usual care related to their kidney transplant status",[15],[31],{"name":32,"affiliation":5,"role":33},"Alexandra Bicki, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Principal Investigator","CONTACT","415-476-3548","alexandra.bicki@ucsf.edu",[41],{"facility":5,"status":25,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"San Francisco","California","94158","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-122.41942,37.77493,{"lat":51,"lon":50},[54],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":55},"alexandra.bicki@uscf.edu",{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100601102","phase-4-antibiotics-for-kidney-transplant-recipients-100601102",false,"NCT07106125","Antibiotics for Kidney Transplant Recipients","Trial of Antibiotic Strategies for Kidney Transplant Recipients","TASK","Inclusion Criteria:\n\n* Must be able to take capsules orally\n* Kidney transplant performed at a UCSF facility within the last 6 months\n* Most recent glomerular filtration rate (GFR) \\>30 mL\u002Fmin\u002F1.73 m2\n* Tolerated initial 6 months of post-transplant TMP-SMX (defined as no intentional periods of TMP-SMX cessation in first 6 months after transplant due to hyperkalemia, allergic reaction, or unexpected\u002Fexcessive neutropenia)\n* Considered \"high risk for UTI\" after kidney transplant, as defined by one or more of the following: (1) Congenital anomaly of kidney\u002Furinary tract as kidney failure etiology, (2) Diagnosis of neurogenic bladder and\u002For use of clean intermittent catheterization and\u002For nightly continuous urinary drainage, (3) Diabetes mellitus (diagnosed either prior to or new-onset after transplant), (4) History of recurrent UTIs as diagnosed by a provider prior to transplant, (5) Occurrence of any UTI in first 6 months after transplant, (6) Delayed graft function (defined as need for dialysis within 7 days of transplant)\n\nExclusion Criteria:\n\n* History of intolerance or allergy to trimethoprim (TMP) and\u002For sulfamethoxazole (SMX)\n* History of UTI due to a TMP-SMX-resistant organism in the first 6 months after transplant\n* Moderate or severe neutropenia (absolute neutrophil count \\\u003C1,000 cells\u002FμL) on most recent bloodwork available at the time of recruitment\n* Uncontrolled hyperkalemia (serum potassium ≥5.0 mEq\u002FL) on most recent bloodwork available at the time of recruitment\n* Provider-determined\u002Fdocumented need for either continuation or discontinuation of TMP-SMX prophylaxis that would preclude the patient's randomization\n* Current pregnancy\n* Incarcerated individuals\u002Fprisoners\n* Inability to provide informed consent or assent, and no legally authorized representative available","ALL","29 Years",{"count":69,"type":70},50,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","The goal of this clinical trial is to learn if a common antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who recently had a kidney transplant. Most people take TMP-SMX for about 6 months after getting a kidney transplant. In this study, researchers want to see what happens if people keep taking it for 6 more months.\n\nThe main questions this study is asking are:\n\n* Does TMP-SMX lower the number of UTIs in the first year after transplant?\n* What side effects or problems do participants have while taking TMP-SMX?\n\nResearchers will compare TMP-SMX to a placebo (a look-alike pill that does not contain any medication) to see if TMP-SMX works to prevent UTIs.\n\nParticipants will:\n\n* Take either TMP-SMX or a placebo pill by mouth every day for 6 months\n* Have three visits to touch base with the study team about any issues\n* Complete short monthly online surveys about any symptoms or side effects\n* Share blood and urine test results from their regular transplant clinic visits",[76,77,78,79,80],"Kidney Transplant","Urinary Tract Infection(UTI)","Antibiotic Prophylaxis","Remote Patient Monitoring","Feasibility Pilot Study",[82,83,84,85,86],"kidney transplant","UTI prevention","antibiotic prophylaxis","decentralized trial","remote clinical trial","NOT_YET_RECRUITING","2025-10-29",{"date":90,"type":91},"2025-10-31","ACTUAL",{"date":93,"type":70},"2026-11",{"date":95,"type":70},"2029-01",{"name":5,"class":6},1]