Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Neurogenic Bladder Clinical Trial

— Alfahydro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576823
• Other study ID #: EFC6269
• Secondary ID: SL7704992004-002
• Status: Completed
• Phase: Phase 3
• First received: December 18, 2007
• Last updated: October 21, 2014
• Start date: December 2007
• Est. completion date: October 2009

Study information

• Verified date: October 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPoland: Ministry of HealthSerbia: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Description:

The study consisted of 2 phases:

• a 12-week efficacy phase then,

• a 40-week safety extension phase.

All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets.

Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase.

All patients had a one-week follow-up period after the last dose intake.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• a-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 a-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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hydronephrosis
• Neurogenic Bladder
• Urinary Bladder, Neurogenic

Intervention

Drug:
• Alfuzosin
Dose: 0.2 mg/kg/day Route: oral

Locations

Country	Name	City	State
Bulgaria	Sanofi-Aventis Administrative Office	Sofia
Canada	Sanofi-Aventis Administrative Office	Laval
Estonia	Sanofi-Aventis Administrative Office	Tallin
India	Sanofi-Aventis Administrative Office	Mumbai
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Poland	Sanofi-Aventis Administrative Office	Warszawa
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Serbia	Sanofi-Aventis Administrative Office	Belgrade
Singapore	Sanofi-Aventis Aministrative Office	Singapore
Slovakia	Sanofi-Aventis Administrative Office	Bratislava
Taiwan	Sanofi-Aventis Administrative Office	Taipei
Turkey	Sanofi-Aventis Administrative Office	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Bulgaria,  Canada,  Estonia,  India,  Malaysia,  Poland,  Russian Federation,  Serbia,  Singapore,  Slovakia,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes	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.	12 weeks (efficacy study phase)	No
Secondary	Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes		52 weeks (efficacy and extension study phases)	No