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

NCT00004487 | Unknown Phase 3

• 3 other identifiers: 199/14267REPRO-FDR001514REPRO-99-07
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vesicoureteral Reflux

Keywords

rare disease; renal and genitourinary disorders; vesicoureteral reflux

Interventions

chondrocyte-alginate gel suspension DRUG

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• FDA Office of Orphan Products Development: lead
• Curis, Inc.: collaborator

MeSH Terms

Conditions

Vesico-Ureteral Reflux; Rare Diseases; Urogenital Diseases

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank T. Gentile

  Curis, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: May 1, 1999
• Last Updated: March 25, 2015

Record last verified: 2001-04