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Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux

Primary Purpose

Vesicoureteral Reflux

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
chondrocyte-alginate gel suspension
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vesicoureteral Reflux focused on measuring rare disease, renal and genitourinary disorders, vesicoureteral reflux

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    Curis, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004487
    Brief Title
    Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2001
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1999 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    Curis, Inc.

    4. Oversight

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vesicoureteral Reflux
    Keywords
    rare disease, renal and genitourinary disorders, vesicoureteral reflux

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    chondrocyte-alginate gel suspension

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank T. Gentile
    Organizational Affiliation
    Curis, Inc.
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux

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