Antibiotics for Kidney Transplant Recipients (TASK)

University of California San Francisco (UCSF)

Status and phase: Begins enrollment in a year or more; Phase 4

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

Treatments: Other: Usual Care; Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)

Study type: Interventional

Funder types: Other

Identifiers

NCT07106125

25-44366

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 13 to 29 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 13-29 years at time of recruitment
• 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) Diabetes mellitus (diagnosed either prior to or new-onset after transplant), (3) History of recurrent UTIs as diagnosed by a provider prior to transplant, (4) Occurrence of any UTI in first 6 months after transplant, (5) Delayed graft function (defined as need for dialysis within 7 days of transplant)
• Patient and/or caregiver ability to read and understand English or Spanish

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 (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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Drug

Experimental group

Description:

TMP-SMX

Treatment:

Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Usual Care