Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2026-11-30
2029-01-31
Brief Summary
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The main questions this study is asking are:
* Does TMP-SMX lower the number of UTIs in the first year after transplant?
* What side effects or problems do participants have while taking TMP-SMX?
Researchers 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.
Participants will:
* Take either TMP-SMX or a placebo pill by mouth every day for 6 months
* Have three visits to touch base with the study team about any issues
* Complete short monthly online surveys about any symptoms or side effects
* Share blood and urine test results from their regular transplant clinic visits
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Drug
TMP-SMX
Trimethoprim-Sulfamethoxazole (TMP-SMX)
Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
Placebo
Placebo
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
Interventions
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Trimethoprim-Sulfamethoxazole (TMP-SMX)
Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
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
Eligibility Criteria
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Inclusion Criteria
* Kidney transplant performed at a UCSF facility within the last 6 months
* Most recent glomerular filtration rate (GFR) \>30 mL/min/1.73 m2
* 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/excessive neutropenia)
* Considered "high risk for UTI" after kidney transplant, as defined by one or more of the following: (1) Congenital anomaly of kidney/urinary tract as kidney failure etiology, (2) Diagnosis of neurogenic bladder and/or use of clean intermittent catheterization and/or 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)
Exclusion Criteria
* History of UTI due to a TMP-SMX-resistant organism in the first 6 months after transplant
* Moderate or severe neutropenia (absolute neutrophil count \<1,000 cells/μL) on most recent bloodwork available at the time of recruitment
* Uncontrolled hyperkalemia (serum potassium ≥5.0 mEq/L) on most recent bloodwork available at the time of recruitment
* Provider-determined/documented need for either continuation or discontinuation of TMP-SMX prophylaxis that would preclude the patient's randomization
* Current pregnancy
* Incarcerated individuals/prisoners
* Inability to provide informed consent or assent, and no legally authorized representative available
29 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Alexandra Bicki, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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25-44366
Identifier Type: -
Identifier Source: org_study_id
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