Antibiotics for Kidney Transplant Recipients

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07106125
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 29 Years
Healthy Volunteers
Not accepted

Interventions

  • Trimethoprim-Sulfamethoxazole (TMP-SMX) — DRUG
    Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
  • Usual Care — OTHER
    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

Study Details

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

Key Dates

Start date
Nov 30, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Drug
    TMP-SMX
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Principal Investigator
[email protected]
415-476-3548

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By research site
University of California, San Francisco· San Francisco, CA

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