Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

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”

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).

The study consisted of 2 phases: - a 12-week efficacy phase then, - a 40-week safety extension phase.

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Alfuzosin solution - 2-7 years
  • Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
• Experimental: Alfuzosin solution - 8-16 years
  • 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.
• Experimental: Alfuzosin tablet - 8-16 years
  • 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.

Primary Measures

• Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis
  • Time Frame: baseline and 12 weeks (efficacy study phase)
    Safety Issue?: No

Secondary Measures

• Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
  • Time Frame: 12 weeks (efficacy study phase)
    Safety Issue?: No
• Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
  • Time Frame: 52 weeks (efficacy and extension study phases)
    Safety Issue?: No

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.
• 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

ICD CSD Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00576823

Study ID Number: EFC6269

ClinicalTrials.gov Identifier: NCT00576823

Health Authority: United States: Food and Drug Administration