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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00576823
First received: December 18, 2007
Last updated: October 21, 2014
Last verified: October 2014
  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.

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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Sanofi
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: October 21, 2014
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:
Hydronephrosis
Urinary Bladder, Neurogenic
Kidney Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Alfuzosin
Adrenergic Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Urological Agents

ClinicalTrials.gov processed this record on October 29, 2014