HydronephrosisPhase 3AlfahydroNCT00576823
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
A Phase 3 study testing Alfuzosin in people with Hydronephrosis and Neurogenic Bladder, run by Sanofi at 12 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Hydronephrosis, Neurogenic Bladder
- What is being tested?
- Alfuzosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 12 sitesin 12 countries
- Study dates
- Dec 2007to Oct 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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 locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
About this study
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
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).
Read the 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.
- Conditions
- Hydronephrosis, Neurogenic Bladder
- Being tested
- Alfuzosin
- Keywords
- child, bladder, neuropathic, alpha blockers
- Medical subject headings
- Hydronephrosis, Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
Also called SL770499
Dose: 0.2 mg/kg/day
Route: oral
| Study group | Role | What they receive |
|---|---|---|
| Alfuzosin solution - 2-7 years | Experimental | Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age. Receives: Drug: Alfuzosin |
| Alfuzosin solution - 8-16 years | Experimental | 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. Receives: Drug: Alfuzosin |
| Alfuzosin tablet - 8-16 years | Experimental | 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. Receives: Drug: Alfuzosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12 weeks (efficacy study phase)
Secondary outcomes (2)
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.
Measured: 12 weeks (efficacy study phase)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Measured: 52 weeks (efficacy and extension study phases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJan 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HydronephrosisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576823
- Sponsor's protocol ID
- EFC6269
- Other IDs
- SL770499, 2004-002397-38, 2004
- Acronym
- Alfahydro
- Status last verified
- Oct 2014
- First submitted
- 18 Dec 2007
- Last updated
- 29 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00576823
- Acronym / sponsor ID
- Alfahydro / EFC6269
- Conditions
- Hydronephrosis, Neurogenic Bladder
- Keywords
- child, bladder, neuropathic, alpha blockers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 8 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alfuzosin solution - 2-7 years | Experimental | Drug: AlfuzosinAlfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age. |
| Alfuzosin solution - 8-16 years | Experimental | Drug: AlfuzosinAlfuzosin 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 - 8-16 years | Experimental | Drug: AlfuzosinAlfuzosin 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. |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlfuzosinAlso: SL770499Dose: 0.2 mg/kg/day Route: oral | Drug | Alfuzosin solution - 2-7 years, Alfuzosin solution - 8-16 years, Alfuzosin tablet - 8-16 years |
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.
2 secondary outcomes
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Time frame: 12 weeks (efficacy study phase)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Time frame: 52 weeks (efficacy and extension study phases)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfuzosin in people with Hydronephrosis and Neurogenic Bladder, run by Sanofi at 12 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Bulgaria, Canada, Estonia, India, Malaysia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2014.