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NCT06409819 · ClinicalTrials.gov registry record · Phase 1
Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients
A Phase 1 study of Urinary Tract Infection, Recurrent, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT06409819: Recruiting Phase 1 study of Urinary Tract Infection, Recurrent, sponsored by University of California, San Diego.
NCT06409819 is a Phase 1 study of Urinary Tract Infection, Recurrent that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06409819, a Phase 1 study of Urinary Tract Infection, Recurrent, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This proposal will take an important first step in the study of phage therapy for treatment of recurrent urinary tract infection (rUTI) in female kidney transplant recipients (KTR); a common condition that is associated with increasing multidrug resistance, sickness, loss of kidney function and death. The investigators will conduct a randomized phase I/II pilot clinical trial of targeted phage therapy versus placebo in asymptomatic female KTR with a history of rUTI due to Escherichia coli to assess safety, tolerability, and feasibility of this approach, possible efficacy, and changes in the gut and urinary microbiome during the 180 days of the study. This highly innovative and impactful proposal will provide proof of concept data and also inform the design of a subsequent larger phase III clinical trial of phage therapy for rUTI treatment in KTR and will have broad downstream effects within the fields of infectious diseases and transplantation.
Primary Outcome
Safety of phage administration will be assessed by the incidence of adverse events (AE) as assessed by CTCAE v4.0. As this is a phase 1/ 2 pilot clinical study, the primary outcome is safety and tolerability of the IP.
Conditions Studied
Interventions
- DRUG phage therapy
- DRUG control
Study Locations (1)
California
- University of California, San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2025-06-15 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 1 |
What NCT06409819 shows while recruiting
NCT06409819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Urinary Tract Infection, Recurrent appearing as the primary indexed condition, and to 2 interventions - of which phage therapy is the first listed.
NCT06409819 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06409819 about?
NCT06409819 is a clinical study titled "Phage Therapy for Recurrent UTIs in Kidney Transplant Recipients". This proposal will take an important first step in the study of phage therapy for treatment of recurrent urinary tract infection (rUTI) in female kidney transplant recipients (KTR); a common condition that is associated with increasing multidrug resistance, sickness, loss of kidney function and deat...
What is the current status of trial NCT06409819?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2025-06-15. Estimated completion is 2027-03-01.
What conditions does trial NCT06409819 study?
This clinical trial studies the following conditions: Urinary Tract Infection, Recurrent.
What interventions are being tested in trial NCT06409819?
The interventions under investigation include: phage therapy (DRUG), control (DRUG).
Who is sponsoring clinical trial NCT06409819?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06409819 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06409819's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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