Kidney TransplantPhase 4TASKNCT07106125
Antibiotics for Kidney Transplant Recipients
A Phase 4 study testing Trimethoprim-Sulfamethoxazole (TMP-SMX) in people with Kidney Transplant and Urinary Tract Infection(UTI), run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 29 years
- Conditions the study is for
- Kidney Transplant, Urinary Tract Infection(UTI), Antibiotic Prophylaxis
- What is being tested?
- Trimethoprim-Sulfamethoxazole (TMP-SMX)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2028to Dec 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
Principal Investigator, 415-476-3548, alexandra.bicki@uscf.edu
About this study
Official title: Trial of Antibiotic Strategies for Kidney Transplant Recipients
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:
Read more
- 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
- Being tested
- Trimethoprim-Sulfamethoxazole (TMP-SMX), Usual Care
- Keywords
- kidney transplant, UTI prevention, antibiotic prophylaxis, decentralized trial, remote clinical trial
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim-Sulfamethoxazole (TMP-SMX)Drug
Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant
Usual CareOther
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 group | Role | What they receive |
|---|---|---|
| Drug | Experimental | TMP-SMX Receives: Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX) |
| Placebo | Placebo comparator | Placebo Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From enrollment to the end of the study drug period (6 months)
Secondary outcomes (4)
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.
Measured: From enrollment through the end of the study period (12 months)
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.
Measured: From enrollment to the end of the study period (12 months)
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.
Measured: From enrollment to the end of the study period (12 months)
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
Measured: From enrollment to the end of the study drug period (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study startOct 2028 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Bicki, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07106125
- Sponsor's protocol ID
- 25-44366
- Acronym
- TASK
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2025
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Antibiotic Strategies for Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07106125
- Acronym / sponsor ID
- TASK / 25-44366
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2028 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Trimethoprim-Sulfamethoxazole (TMP-SMX)TMP-SMX |
| Placebo | Placebo comparator | Other: Usual CarePlacebo |
Who may qualify
- Ages
- 12 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim-Sulfamethoxazole (TMP-SMX)Kidney transplant recipients will continue to take TMP-SMX daily from months 6-12 after transplant | Drug | Drug |
| Usual CareParticipants will take a placebo from months 6-12 after transplant and continue to receive all standard usual care related to their kidney transplant status | Other | Placebo |
Primary outcome
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)
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 Screening
Time frame: Baseline/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-Report
Time frame: From 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 Retention
Time frame: From 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
4 secondary outcomes
Event Rate of All-Cause Hospitalizations by Treatment Arm
Time frame: From enrollment through the end of the study period (12 months)
Urinary Tract Infections by Treatment Arm
Time frame: From enrollment to the end of the study period (12 months)
Acute Kidney Injury Events by Treatment Arm
Time frame: From enrollment to the end of the study period (12 months)
Adverse Events by Treatment Arm
Time frame: From enrollment to the end of the study drug period (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Bicki, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trimethoprim-Sulfamethoxazole (TMP-SMX) in people with Kidney Transplant and Urinary Tract Infection(UTI), run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (415-476-3548, alexandra.bicki@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.