Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology (Alfahydro)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00576823
First received: December 18, 2007
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

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).

Condition Intervention Phase
Hydronephrosis
Neurogenic Bladder
Drug: Alfuzosin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome 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) ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes [ Time Frame: 12 weeks (efficacy study phase) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: December 2007
Study Completion Date: October 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Alfuzosin

Dose: 0.2 mg/kg/day

Route: oral

Other Name: SL770499
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.
Drug: Alfuzosin

Dose: 0.2 mg/kg/day

Route: oral

Other Name: SL770499
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.
Drug: Alfuzosin

Dose: 0.2 mg/kg/day

Route: oral

Other Name: SL770499

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576823

Locations
Bulgaria
Sanofi-Aventis Administrative Office
Sofia, Bulgaria
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Estonia
Sanofi-Aventis Administrative Office
Tallin, Estonia
India
Sanofi-Aventis Administrative Office
Mumbai, India
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Serbia
Sanofi-Aventis Administrative Office
Belgrade, Serbia
Singapore
Sanofi-Aventis Aministrative Office
Singapore, Singapore
Slovakia
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00576823     History of Changes
Other Study ID Numbers: EFC6269, SL770499, 2004-002397-38
Study First Received: December 18, 2007
Results First Received: January 13, 2011
Last Updated: February 15, 2011
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health
Serbia: Ethics Committee

Keywords provided by Sanofi:
child
bladder
neuropathic
alpha blockers

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Hydronephrosis
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Kidney Diseases
Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014