Antibiotics for Kidney Transplant Recipients

NCT07106125 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-44366
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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.

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

• 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.

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

• 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.

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

• Trial Retention

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

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

Secondary Outcomes (4)

• Event Rate of All-Cause Hospitalizations by Treatment Arm

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

• Urinary Tract Infections by Treatment Arm

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

• Acute Kidney Injury Events by Treatment Arm

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

• Adverse Events by Treatment Arm

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

Study Arms (2)

Drug

EXPERIMENTAL

TMP-SMX

Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Usual Care

Interventions

Trimethoprim-Sulfamethoxazole (TMP-SMX) DRUG

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

Drug

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

Placebo

Eligibility Criteria

• Age: Up to 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Alexandra Bicki, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

415-476-3548; alexandra.bicki@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 6, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)