Trial · NCT00405704

Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)

NCT00405704, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2015-04-16

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ConductScience Library. Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR). Trials, record NCT00405704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00405704

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Randomized Intervention for Children With Vesicoureteral Reflux (RIVUR)
NCT number: NCT00405704
Status: Completed
Phases: Phase 3
Enrollment: 607 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Vesicoureteral Reflux, Urinary Tract Infections
Interventions: Trimethoprim-Sulfamethoxazole, Placebo
First posted: 2006-11-30
Last updated: 2020-04-21
Results first posted: 2015-04-16
Limitations and caveats: Results may not apply to children with different demographic or clinical characteristics or in locales where choice of TMP-SMZ may be limited by susceptibility patterns or clinical acceptability. Some subgroup analyses had limited statistical power.

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up	2 years
Secondary	Outcome Renal Scarring	2 years	Renal scarring was defined as a decreased uptake of tracer that was associated with loss of contours or the presence of cortical thinning. Outcome dimercaptosuccinic acid (DMSA) scan was performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Secondary	Severe Renal Scarring on Outcome Scan	2 years	Severe renal scarring was defined as scarring in more than 4 of 12 segments in at least one kidney or global atrophy characterized by diffusely scarred and shrunken kidney. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Secondary	New Renal Scarring on Outcome Scan	2 years	New renal scarring was defined as scarring on the outcome renal scan with technetium -99m-labeled dimercaptosuccinic acid that was not present at baseline. Outcome DMSA scan performed at 2 years after enrollment or 3-4 months after the child had met treatment failure criteria.
Secondary	Treatment Failure Composite	2 years	Treatment failure was defined as the occurrence of two febrile urinary tract infections (UTIs), one febrile UTI and three symptomatic UTIs, four symptomatic UTIs, or new or worsening renal scarring on an interim scan (e.g,, the 12-month visit); renal scans from the 2-year visit are NOT considered in the treatment failure criteria.
Secondary	Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)	2 years
Secondary	Recurrent Febrile or Symptomatic UTI With Resistant E. Coli	2 years
Secondary	Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen	2 years

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up	2 years		participants	NUMBER
SECONDARY	Outcome Renal Scarring	2 years	The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.	participants	NUMBER
SECONDARY	Severe Renal Scarring on Outcome Scan	2 years	The analysis population excluded 75 subjects in the trimethoprim-sulfamethoxazole group and 70 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.	participants	NUMBER
SECONDARY	New Renal Scarring on Outcome Scan	2 years	The analysis population excluded 82 subjects in the trimethoprim-sulfamethoxazole group and 78 subjects in the placebo group who did not have an outcome dimercaptosuccinic acid scan.	participants	NUMBER
SECONDARY	Treatment Failure Composite	2 years		participants	NUMBER
SECONDARY	Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)	2 years	The analysis population excluded 99 subjects in the trimethoprim-sulfamethoxazole group and 95 subjects in the placebo group who did not have stool analyzed at the outcome visit.	participants	NUMBER
SECONDARY	Recurrent Febrile or Symptomatic UTI With Resistant E. Coli	2 years	The analysis population is restricted to the 30 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 57 subjects in the placebo group who had a recurrent UTI with E. coli for which sensitivity to TMP-SMZ was assessed.	participants	NUMBER
SECONDARY	Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen	2 years	The analysis population is restricted to the 38 subjects in the trimethoprim-sulfamethoxazole (TMP-SMZ) group and 69 subjects in the placebo group who had a recurrent UTI with an organism for which sensitivity to TMP-SMZ was assessed.	participants	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up	Trimethoprim-Sulfamethoxazole	39	participants
Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up	Placebo	72	participants
Outcome Renal Scarring	Trimethoprim-Sulfamethoxazole	27	participants
Outcome Renal Scarring	Placebo	24	participants
Severe Renal Scarring on Outcome Scan	Trimethoprim-Sulfamethoxazole	9	participants
Severe Renal Scarring on Outcome Scan	Placebo	6	participants
New Renal Scarring on Outcome Scan	Trimethoprim-Sulfamethoxazole	18	participants
New Renal Scarring on Outcome Scan	Placebo	19	participants
Treatment Failure Composite	Trimethoprim-Sulfamethoxazole	14	participants
Treatment Failure Composite	Placebo	27	participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Trimethoprim-Sulfamethoxazole	302
Overall Study	STARTED	Placebo	305
Overall Study	Completed Outcome Renal Scan	Trimethoprim-Sulfamethoxazole	227
Overall Study	Completed Outcome Renal Scan	Placebo	235
Overall Study	Completed Assessments for New Scarring	Trimethoprim-Sulfamethoxazole	220
Overall Study	Completed Assessments for New Scarring	Placebo	227
Overall Study	Outcome Stool Assessed	Trimethoprim-Sulfamethoxazole	203
Overall Study	Outcome Stool Assessed	Placebo	210
Overall Study	Recurrent UTI With E. Coli	Trimethoprim-Sulfamethoxazole	30
Overall Study	Recurrent UTI With E. Coli	Placebo	57

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Fever	General disorders	Trimethoprim-Sulfamethoxazole	43	302	58
other	Fever	General disorders	Placebo	55	305	80
other	Otitis Media	General disorders	Trimethoprim-Sulfamethoxazole	13	302	18
other	Otitis Media	General disorders	Placebo	24	305	33
other	Pharyngitis	General disorders	Trimethoprim-Sulfamethoxazole	19	302	25
other	Pharyngitis	General disorders	Placebo	14	305	20
other	Rash	General disorders	Trimethoprim-Sulfamethoxazole	23	302	30
other	Rash	General disorders	Placebo	23	305	26
other	Viral Infection	General disorders	Trimethoprim-Sulfamethoxazole	14	302	14
other	Viral Infection	General disorders	Placebo	16	305	20

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Trimethoprim-Sulfamethoxazole
Total, all-cause mortality	Placebo
Total, other adverse events	Trimethoprim-Sulfamethoxazole	79	302
Total, other adverse events	Placebo	105	305
Total, serious adverse events	Trimethoprim-Sulfamethoxazole	0	302
Total, serious adverse events	Placebo	0	305

Source ClinicalTrials.gov

Papers14

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
18076937	BACKGROUND	PubMed
19018047	BACKGROUND	PubMed
19018048	BACKGROUND	PubMed
19086141	BACKGROUND	PubMed
19450818	BACKGROUND	PubMed
19570724	BACKGROUND	PubMed
22910235	BACKGROUND	PubMed
23044377	BACKGROUND	PubMed
23546617	BACKGROUND	PubMed
23753091	RESULT	PubMed

1 to 10 of 14

See all 14 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK074059	Randomized Intervention for Vesicoureteral Reflux (RIVUR)	CARPENTER, MYRA A.	UNIV OF NORTH CAROLINA CHAPEL HILL	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2005 to 2012

Source NIH RePORTER

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Trimethoprim-Sulfamethoxazole vs Placebo: New Renal Scarring on Outcome Scan	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: Presence of E.Coli Resistant to Trimethoprim-Sulfamethoxazole (TMP-SMZ) (Based on Rectal Swab)	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: Recurrent Febrile or Symptomatic UTI With Resistant E. Coli	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: Outcome Renal Scarring	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: Recurrent Febrile or Symptomatic UTI With Any Resistant Pathogen	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: Severe Renal Scarring on Outcome Scan	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: Recurrent Febrile or Symptomatic Urinary Tract Infection During 2-year Follow-up	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: Treatment Failure Composite	Trial comparisons
Trimethoprim-Sulfamethoxazole vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00405704

GET https://conductscience.org/api/trials/v1/NCT00405704/registered

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