ClinicalTrials.gg
Not yet recruitingNCT07106125TASKUpdated Sep 11, 2026

Antibiotics for Kidney Transplant Recipients

A Phase 4 interventional study of Trimethoprim-Sulfamethoxazole (TMP-SMX) and Usual Care in Kidney Transplant, Urinary Tract Infection(UTI) and Antibiotic Prophylaxis, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by University of California, San Francisco · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
12 Years to 29 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 271 studies in Urinary Tract Infections with a site in United States — 44 open to participants now, 54 under way, 2 of them phase 3. Urinary Tract Infections · United States.

Planned enrollment
147th of 222
50 · median 100
Started
2028
with 1 other
Phase 4
38 of 271
9 open now
Primary completion
2031-12
later than 53 of 53 live
Registered
250th of 271
by date
Lead sponsor
6 of 271
University of California, San Francisco

Among the 271 studies in Urinary Tract Infections with a site in United States, this one is the 147th largest by planned enrollment of the 222 interventional ones that give a count, is one of 2 that started in 2028, is one of 38 in phase 4, reaches primary completion later than 53 of the 53 other live ones, and was the 250th registered.

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

Browse Urinary Tract Infections studies →

Open to participants now

44 of the 271 studies in Urinary Tract Infections with a site in United States are open now. Recruiting first, the newest first:

39 more — sign in →

All 44 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 84 Urinary Tract Infections studies recruiting now, 50 (60%) set no upper age limit and 23 (27%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.

This study: 12 Years to 29 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

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
03

Conditions studied

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

Keywords

  • kidney transplant
  • UTI prevention
  • antibiotic prophylaxis
  • decentralized trial
  • remote clinical trial
04

Who can participate

Ages eligible
12 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able to take capsules orally
  • Kidney transplant performed at a UCSF facility within the last 6 months
  • Most recent (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)

Exclusion criteria

Exclusion Criteria:

  • 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 ( \<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 or assent, and no legally authorized representative available
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Drug

    TMP-SMX

    Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)

  • Placebo comparator
    Placebo

    Placebo

    Other: Usual Care

Interventions

  • DrugTrimethoprim-Sulfamethoxazole (TMP-SMX)

    Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant

  • OtherUsual 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

06

What researchers measure

Primary outcomes

  1. Agreement Between Participant Self-Report and Medical Records on Clinical Events (Measured by Cohen's Kappa)

    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.

    Time frame: From enrollment to the end of the study drug period (6 months)

  2. Number of Participants Who Enroll After Screening

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

    Time frame: Baseline/Study Day 1 (i.e., date that informed consent is signed for those who choose to participate)

  3. Medication Adherence Assessed by Self-Report

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

    Time frame: From enrollment to the end of the study drug period (6 months)

  4. Trial Retention

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

    Time frame: From enrollment to the end of the study drug period (6 months)

Secondary outcomes

  1. Event Rate of All-Cause Hospitalizations by Treatment Arm

    The investigators will keep track of when participants are hospitalized, using feedback from participants themselves (for the first 6 months) as well as data from their electronic medical records (for 6 additional months, for a total of 12 months). Event rates will be used to compare outcomes between the treatment (TMP-SMX continuation) and placebo arms.

    Time frame: From enrollment through the end of the study period (12 months)

  2. Urinary Tract Infections by Treatment Arm

    The investigators will keep track of when participants report having a urinary tract infection, using feedback from participants themselves (for the first 6 months) as well as data from their electronic medical records (for 6 additional months, for a total of 12 months). Event rates will be used to compare outcomes between the treatment (TMP-SMX continuation) and placebo arms.

    Time frame: From enrollment to the end of the study period (12 months)

  3. Acute Kidney Injury Events by Treatment Arm

    The investigators will keep track of when participants report having acute kidney injury events, using feedback from participants themselves (for the first 6 months) as well as data from their electronic medical records (for 6 additional months, for a total of 12 months). Event rates will be used to compare outcomes between the treatment (TMP-SMX continuation) and placebo arms.

    Time frame: From enrollment to the end of the study period (12 months)

  4. Adverse Events by Treatment Arm

    The investigators will keep track of when participants report side effects and adverse events, using feedback from participants themselves as well as data from their electronic medical records

    Time frame: From enrollment to the end of the study drug period (6 months)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Due to ethical considerations, the access, distribution, and reuse of the resulting scientific data will not be permitted. The study involves minors and a sample size that may be prone to "small cells" (using the Centers for Medicare and Medicaid definition of \<10 individuals with certain characteristics). We will not share individual-participant level data.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2028; primary completion for Dec 2031, 38 months later.

Of 44 non-industry phase 4 interventional studies under Urinary Tract Infections, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 38 months is close to that.

Counting every sponsor, half of 50 studies reached it within 37 months; a quarter within 22 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2025
First posted
Aug 6, 2025
StartEst.
Oct 2028
Primary completionEst.
Dec 2031
CompletionEst.
Dec 2033
Last update
Sep 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07106125
Responsible party
Sponsor
First posted
Aug 6, 2025
Start date
Oct 2028 (estimated)
Primary completion
Dec 2031 (estimated)
Completion
Dec 2033 (estimated)
Last update
Sep 11, 2026

Study contacts

Principal Investigator
Contact
alexandra.bicki@ucsf.edu
415-476-3548
Alexandra Bicki, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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