NCT00576823|CompletedPhase 3ResultsDMC

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Alfahydro

12-week, Multicenter, Open-label, Non-comparative Study to Investigate Pharmacodynamic and Safety of Alfuzosin 0.2 mg/kg/Day in the Treatment of Children and Adolescents 2 - 16 Years of Age With Hydronephrosis Associated With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension

Sanofi ClinicalTrials.gov

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3 other identifiers

EFC6269SL7704992004-002397-38

Study Type

interventional

Target

Locations

12 countries

Sites

Timeline

RegisteredDec 2007

StartedDec 2007

CompletionOct 2009

Brief Summary

Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure \[LPP\] of neuropathic etiology. Secondary objectives were:

To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents,
To investigate the number of Urinary Tract Infection (UTI) episodes,
To investigate the pharmacokinetics of Alfuzosin (population kinetics).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Dec 2007

Geographic Reach

12 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

Study Start

First participant enrolled

December 1, 2007

Completed

17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed

1.4 years until next milestone

Results Posted

Study results publicly available

February 8, 2011

Completed

Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

December 18, 2007

Results QC Date

January 13, 2011

Last Update Submit

October 21, 2014

Conditions

Hydronephrosis Neurogenic Bladder

Keywords

childbladderneuropathicalpha blockers

Outcome Measures

Primary Outcomes (1)

Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis
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.
baseline and 12 weeks (efficacy study phase)

Secondary Outcomes (2)

Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
12 weeks (efficacy study phase)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
52 weeks (efficacy and extension study phases)

Study Arms (3)

Alfuzosin solution - 2-7 years

EXPERIMENTAL

Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.

Drug: Alfuzosin

Alfuzosin solution - 8-16 years

EXPERIMENTAL

Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow tablets or preferred to take the solution or had a body weight \< 30 kg.

Drug: Alfuzosin

Alfuzosin tablet - 8-16 years

EXPERIMENTAL

Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30 kg.

Drug: Alfuzosin

Interventions

AlfuzosinDRUG

Dose: 0.2 mg/kg/day Route: oral

Also known as: SL770499

Alfuzosin solution - 2-7 yearsAlfuzosin solution - 8-16 yearsAlfuzosin tablet - 8-16 years

Eligibility Criteria

Age2 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

You may not qualify if:

Hydronephrosis of non-neuropathic etiology.
Urological surgery in the last 4 months prior to the study.
Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.
α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.
Detrusor injections of botulinum toxin in the last 6 months.
Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele).
History of intolerance to α-blocker therapy.
Orthostatic hypotension.
History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.