Clinical Trial: Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
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).
Detailed Summary:
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.
Sponsor: Sanofi
Current Primary Outcome: 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) ]
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.
Original Primary Outcome: Change in grade of hydronephrosis [ Time Frame: at week 12 (end of efficacy study phase) ]
Current Secondary Outcome:
- Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes [ Time Frame: 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.
- Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes [ Time Frame: 52 weeks (efficacy and extension study phases) ]
Original Secondary Outcome:
- Number of documented urinary tract infections [ Time Frame: after 12 weeks and 52 weeks (end of safety extension phase) ]
- Pharmacokinetics of alfuzosin [ Time Frame: 52 weeks ]
- Safety of alfuzosin [ Time Frame: 52 weeks ]
Information By: Sanofi
Dates:
Date Received: December 18, 2007
Date Started: December 2007
Date Completion:
Last Updated: October 21, 2014
Last Verified: October 2014