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

Primary Purpose

Hydronephrosis, Neurogenic Bladder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hydronephrosis focused on measuring child, bladder, neuropathic, alpha blockers

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Aministrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alfuzosin solution - 2-7 years

Alfuzosin solution - 8-16 years

Alfuzosin tablet - 8-16 years

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes

Full Information

First Posted
December 18, 2007
Last Updated
October 21, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00576823
Brief Title
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hydronephrosis, Neurogenic Bladder
Keywords
child, bladder, neuropathic, alpha blockers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alfuzosin solution - 2-7 years
Arm Type
Experimental
Arm Description
Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
Arm Title
Alfuzosin solution - 8-16 years
Arm Type
Experimental
Arm Description
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.
Arm Title
Alfuzosin tablet - 8-16 years
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alfuzosin
Other Intervention Name(s)
SL770499
Intervention Description
Dose: 0.2 mg/kg/day Route: oral
Primary Outcome Measure Information:
Title
Number of Participants With a Decrease From Baseline ≥ 1 in the Society of Fetal Urology (SFU) Grade of Hydronephrosis
Description
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.
Time Frame
baseline and 12 weeks (efficacy study phase)
Secondary Outcome Measure Information:
Title
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Description
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.
Time Frame
12 weeks (efficacy study phase)
Title
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Time Frame
52 weeks (efficacy and extension study phases)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Sofia
Country
Bulgaria
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
Facility Name
Sanofi-Aventis Administrative Office
City
Tallin
Country
Estonia
Facility Name
Sanofi-Aventis Administrative Office
City
Mumbai
Country
India
Facility Name
Sanofi-Aventis Administrative Office
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Belgrade
Country
Serbia
Facility Name
Sanofi-Aventis Aministrative Office
City
Singapore
Country
Singapore
Facility Name
Sanofi-Aventis Administrative Office
City
Bratislava
Country
Slovakia
Facility Name
Sanofi-Aventis Administrative Office
City
Taipei
Country
Taiwan
Facility Name
Sanofi-Aventis Administrative Office
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

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