Vesicoureteral RefluxPhase 3NCT00004487
Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
A Phase 3 study testing chondrocyte-alginate gel suspension in people with Vesicoureteral Reflux, run by FDA Office of Orphan Products Development.
Trial summary
OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux. II. Determine the long term efficacy of this treatment regimen in this patient population. III. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Vesicoureteral Reflux
- What is being tested?
- chondrocyte-alginate gel suspension
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 1999to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Confirmed grade 3 or 4 reflux in at least one ureter by voiding cystourethrogram Breakthrough urinary tract infection despite standard antibiotic therapy OR Persistent reflux unlikely to resolve spontaneously
- Grade 3: 2 year reflux duration OR 1 breakthrough infection Grade 4: 1 year reflux duration OR 1 breakthrough infection
- Coexisting grade 1 or 2 reflux OR Resolved reflux (i.e., contralateral to the existing grade 3 or 4 refluxing ureter) allowed
- No reflux secondary to obstruction or neuropathic disease
- No gross urological abnormalities (e.g., megaureter requiring ureteral tapering or duplicity of ureters)
--Prior/Concurrent Therapy--
- Surgery: No prior surgery for correction of reflux No recent prior urological device implantation
--Patient Characteristics--
- Hematopoietic: No history of bleeding disorders
- Cardiovascular: No history of hypertension or cardiac disease
- Pulmonary: No history of pulmonary disease
- Other: No known allergies to contrast dyes, iodine, or shellfish No contraindications to general anesthesia No prior infections (other than UTIs) No immunodeficiencies No metabolic disease No social situation that would interfere with follow up Not pregnant Negative pregnancy test
About this study
OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux.
II. Determine the long term efficacy of this treatment regimen in this patient population.
III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population.
IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.
Read the detailed description
PROTOCOL OUTLINE: This is a multicenter study. Patients undergo biopsy of the auricular cartilage for chondrocytes during cystoscopic evaluation on day 1. Chondrocyte alginate gel suspension is injected into the submucosa of the bladder at the vesicoureteral junction between days 40-50. Patients found to have post treatment reflux may be retreated once.
Patients are followed at 1, 3, and 12 months.
- Conditions
- Vesicoureteral Reflux
- Being tested
- chondrocyte-alginate gel suspension
- Keywords
- rare disease, renal and genitourinary disorders, vesicoureteral reflux
- Medical subject headings
- Vesico-Ureteral Reflux, Rare Diseases, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chondrocyte-alginate gel suspensionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vesicoureteral RefluxStudies of the same condition, open and under way.
- 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
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- FDA Office of Orphan Products Development
- Sponsor type
- US federal agency
- Collaborators
- Curis, Inc.
- Investigators
- Frank T. Gentile, Study chair, Curis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004487
- Sponsor's protocol ID
- 199/14267
- Other IDs
- REPRO-FDR001514, REPRO-99-07
- Status last verified
- Apr 2001
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
- ClinicalTrials.gov ID
- NCT00004487
- Acronym / sponsor ID
- 199/14267
- Conditions
- Vesicoureteral Reflux
- Keywords
- rare disease, renal and genitourinary disorders, vesicoureteral reflux
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- FDA Office of Orphan Products DevelopmentUS federal agency
- Collaborators
- Curis, Inc.
- Study start
- May 1999
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux.
II. Determine the long term efficacy of this treatment regimen in this patient population.
III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population.
IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.
Detailed description
PROTOCOL OUTLINE: This is a multicenter study. Patients undergo biopsy of the auricular cartilage for chondrocytes during cystoscopic evaluation on day 1. Chondrocyte alginate gel suspension is injected into the submucosa of the bladder at the vesicoureteral junction between days 40-50. Patients found to have post treatment reflux may be retreated once.
Patients are followed at 1, 3, and 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| chondrocyte-alginate gel suspension | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
Frank T. Gentile study chair
Curis, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chondrocyte-alginate gel suspension in people with Vesicoureteral Reflux, run by FDA Office of Orphan Products Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 25 Mar 2015.