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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2001 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Curis, Inc.
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004487
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: April 2001
History of Changes

October 18, 1999
June 23, 2005
May 1999
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Complete list of historical versions of study NCT00004487 on ClinicalTrials.gov Archive Site
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Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
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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.

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.
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Vesicoureteral Reflux
Drug: chondrocyte-alginate gel suspension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
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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
Both
6 Months to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004487
199/14267, REPRO-FDR001514, REPRO-99-07
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FDA Office of Orphan Products Development
Curis, Inc.
Study Chair: Frank T. Gentile Curis, Inc.
FDA Office of Orphan Products Development
April 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP