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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Hydronephrosis; Neurogenic Bladder

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00576823

SL770499

2004-002397-38 (EudraCT Number)

EFC6269

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Alfuzosin solution - 2-7 years

Experimental group

Description:

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

Treatment:

Drug: Alfuzosin

Alfuzosin solution - 8-16 years

Experimental group

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.

Treatment:

Drug: Alfuzosin

Alfuzosin tablet - 8-16 years

Experimental group

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.

Treatment:

Drug: Alfuzosin