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Antibiotics for Kidney Transplant Recipients

This study is looking at whether the antibiotic trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who have recently had a kidney transplant. Typically, people take TMP-SMX for 6 months after a transplant. This study will compare taking TMP-SMX for an additional 6 months to taking a placebo (an inactive pill) to see if it reduces UTIs and what side effects might occur. You may be able to join if you are under 29 years old, had a kidney transplant at a UCSF facility within the last 6 months, and meet certain health criteria, including a specific kidney function (GFR >30 mL/min/1.73 m2). The study aims to see how well participants report their health events and how consistently they take their medication.

Study design
This is an interventional study with a planned enrollment of 50 participants. It compares taking TMP-SMX to taking a placebo.
What's involved
Participants will take either TMP-SMX or a placebo daily for 6 months, from 6 to 12 months after their transplant. They will also continue to receive standard care for their kidney transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment until the end of the study drug period, which is 6 months.

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NCT07106125

Antibiotics for Kidney Transplant Recipients

Not Yet Recruiting
PHASE4Up to 29InterventionalPrevention
University of California, San Francisco
~50 participants
Updated 2025-10-31 on ClinicalTrials.gov
What's tested:Trimethoprim-Sulfamethoxazole (TMP-SMX)Usual Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa)
Measured over From enrollment to the end of the study drug period (6 months)
+3 more outcomes measured

Conditions

Kidney Transplant
Urinary Tract Infection(UTI)
Antibiotic Prophylaxis
Remote Patient Monitoring
Feasibility Pilot Study

Explore related trials

Kidney TransplantationUrinary Tract Infection

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Alexandra Bicki, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Principal Investigator
[email protected]
415-476-3548
Email the study team

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Eligibility criteria

Inclusion

Must be able to take capsules orally
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

History of intolerance or allergy to trimethoprim (TMP) and/or sulfamethoxazole (SMX)
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

What this trial measures

  • Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa)From enrollment to the end of the study drug period (6 months)

    The investigators will look at how closely participants' self-reports of events (urinary tract and associated infections, acute kidney injury events, and hospitalizations) match what is identified through their electronic health records. To do this, the investigators will use a statistical tool called Cohen's kappa, which shows how much agreement there is between the two sources.

  • Number of Participants Who Enroll After ScreeningBaseline/Study Day 1 (i.e., date that informed consent is signed for those who choose to participate)

    The investigators will track how many people decide to join and how many people decline to join the study after completing the screening process.

  • Medication Adherence Assessed by Self-ReportFrom enrollment to the end of the study drug period (6 months)

    The investigators will ask participants how often they are taking the pills as directed, through monthly surveys and at all study visits.

  • Trial RetentionFrom enrollment to the end of the study drug period (6 months)

    The investigators will keep track of how many participants complete the last study visit