Trial · NCT00576823

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

NCT00576823, Phase 3, Completed, Sanofi; results first posted 2011-02-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology. Trials, record NCT00576823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00576823

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Trial

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

Title: Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
NCT number: NCT00576823
Status: Completed
Phases: Phase 3
Enrollment: 25 participants, actual
Lead sponsor: Sanofi
Conditions: Hydronephrosis, Neurogenic Bladder
Interventions: Alfuzosin
First posted: 2007-12-19
Last updated: 2014-10-29
Other registries' IDs: eudract:2004-002397-38
Results first posted: 2011-02-08
Limitations and caveats: This was an exploratory, open-label, non-comparative trial. Analyses were purely descriptive.

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	baseline and 12 weeks (efficacy study phase)	Hydronephrosis was investigated by ultrasound and graded using SFU classification at each time point. 'Complete response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for both kidneys, or, unilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for the affected kidney without worsening of the other kidney. 'Partial response' was assessed when bilateral hydronephrosis at baseline and grade decrease from baseline ≥ 1 for one kidney without worsening of the other kidney.
Secondary	Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes	12 weeks (efficacy study phase)	When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture. A symptomatic UTI was defined as the presence of symptoms and a positive culture with \> 100 000 Colony Forming Units (CFUs) with a single organism.
Secondary	Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes	52 weeks (efficacy and extension study phases)

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	baseline and 12 weeks (efficacy study phase)	The analysis was on the intent-to-treat (ITT) population (i.e. all included patients who received at least one dose of Alfuzosin) excluding the patients who didn't have baseline SFU grade. Patients without post-baseline SFU grade before Week 12 were included as non-responders.	participants	NUMBER
SECONDARY	Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes	12 weeks (efficacy study phase)	The analysis was performed on the ITT population (i.e. all included patients who received at least one dose of Alfuzosin).	participants	NUMBER
SECONDARY	Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes	52 weeks (efficacy and extension study phases)	The analysis was performed on the exposed population (i.e. all patients who received at least one dose of Alfuzosin regardless of the amount of treatment received).	participants	NUMBER

Source ClinicalTrials.gov

Results by group33

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

Outcome	Group	Category	Value	Units
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Solution - 2-7 Years	Complete response	2	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Solution - 8-16 Years	Complete response	5	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Tablet - 8-16 Years	Complete response	3	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Solution - 2-7 Years	- Bilateral hydronephrosis	1	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Solution - 8-16 Years	- Bilateral hydronephrosis	3	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Tablet - 8-16 Years	- Bilateral hydronephrosis	1	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Solution - 2-7 Years	- Unilateral hydronephrosis	1	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Solution - 8-16 Years	- Unilateral hydronephrosis	2	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Tablet - 8-16 Years	- Unilateral hydronephrosis	2	participants
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis	Alfuzosin Solution - 2-7 Years	Partial response	3	participants

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow18

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

Period	Milestone	Group	Participants
12-week Efficacy Phase	STARTED	Alfuzosin Solution - 2-7 Years	12
12-week Efficacy Phase	STARTED	Alfuzosin Solution - 8-16 Years	6
12-week Efficacy Phase	STARTED	Alfuzosin Tablet - 8-16 Years	7
12-week Efficacy Phase	COMPLETED	Alfuzosin Solution - 2-7 Years	11
12-week Efficacy Phase	COMPLETED	Alfuzosin Solution - 8-16 Years	6
12-week Efficacy Phase	COMPLETED	Alfuzosin Tablet - 8-16 Years	7
12-week Efficacy Phase	NOT COMPLETED	Alfuzosin Solution - 2-7 Years	1
12-week Efficacy Phase	NOT COMPLETED	Alfuzosin Solution - 8-16 Years	0
12-week Efficacy Phase	NOT COMPLETED	Alfuzosin Tablet - 8-16 Years	0
40-week Safety Extension Phase	STARTED	Alfuzosin Solution - 2-7 Years	11

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events150

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
other	CYSTITIS	Infections and infestations	Afluzosin Solution - 2-7 Years	3	12
other	CYSTITIS	Infections and infestations	Afluzosin Solution - 8-16 Years	0	6
other	CYSTITIS	Infections and infestations	Afluzosin Tablets - 8-16 Years	1	7
other	NASOPHARYNGITIS	Infections and infestations	Afluzosin Solution - 2-7 Years	3	12
other	NASOPHARYNGITIS	Infections and infestations	Afluzosin Solution - 8-16 Years	1	6
other	NASOPHARYNGITIS	Infections and infestations	Afluzosin Tablets - 8-16 Years	0	7
other	PHARYNGITIS	Infections and infestations	Afluzosin Solution - 2-7 Years	1	12
other	PHARYNGITIS	Infections and infestations	Afluzosin Solution - 8-16 Years	1	6
other	PHARYNGITIS	Infections and infestations	Afluzosin Tablets - 8-16 Years	1	7
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Afluzosin Solution - 2-7 Years	2	12

1 to 10 of 150Source ClinicalTrials.gov

See all 150 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Afluzosin Solution - 2-7 Years
Total, all-cause mortality	Afluzosin Solution - 8-16 Years
Total, all-cause mortality	Afluzosin Tablets - 8-16 Years
Total, other adverse events	Afluzosin Solution - 2-7 Years	9	12
Total, other adverse events	Afluzosin Solution - 8-16 Years	5	6
Total, other adverse events	Afluzosin Tablets - 8-16 Years	5	7
Total, serious adverse events	Afluzosin Solution - 2-7 Years	2	12
Total, serious adverse events	Afluzosin Solution - 8-16 Years	2	6
Total, serious adverse events	Afluzosin Tablets - 8-16 Years	0	7

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons0

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

None in this release.

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/NCT00576823

GET https://conductscience.org/api/trials/v1/NCT00576823/results?page=2

API reference For AI assistants