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Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
NCT00405704 · View on ClinicalTrials.gov ↗
Study Summary
In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing recurrences (primary outcome). Secondary outcomes were renal scarring, treatment failure (a composite of recurrences and scarring), and antimicrobial resistance.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Trimethoprim-Sulfamethoxazole
Study Locations (19)
Pennsylvania
- Penn State Hershey Medical Center — Hershey
- Children's Hospital of Philadelphia — Philadelphia
- Children's Hospital of Pittsburgh — Pittsburgh
Ohio
- Akron Children's Hospital — Akron
- Cincinnati Children's Hospital — Cincinnati
Alabama
- University of Alabama — Birmingham
Delaware
- Alfred I. duPont Hospital for Children — Wilmington
District of Columbia
- Children's National Medical Center — Washington D.C.
Illinois
- Ann & Robert Lurie Children's Hospital of Chicago — Chicago
Maryland
- Johns Hopkins School of Medicine — Baltimore
Massachusetts
- Children's Hospital of Boston — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 607 participants |
| Start Date | 2007-05 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00405704
The ClinicalTrials.gov registry entry for NCT00405704 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 607 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Urinary Tract Infections appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00405704 reports 19 study locations spanning 16 distinct geographic areas — top geographies include Pennsylvania, Ohio, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00405704 about?
NCT00405704 is a clinical study titled "Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)". In this 2-year, multisite, randomized, placebo-controlled trial involving 607 children with vesicoureteral reflux that was diagnosed after a first or second febrile or symptomatic urinary tract infecton, we evaluated the efficacy of Trimethoprim-Sulfamethoxazole (TMP-SMZ) prophylaxis in preventing r...
What is the current status of trial NCT00405704?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 607 participants. The study started on 2007-05. Estimated completion is 2014-05.
What conditions does trial NCT00405704 study?
This clinical trial studies the following conditions: Urinary Tract Infections, Vesicoureteral Reflux. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00405704?
The interventions under investigation include: Placebo (DRUG), Trimethoprim-Sulfamethoxazole (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00405704?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00405704 being conducted?
This trial has 19 study locations across Alabama, Delaware, District of Columbia, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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