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

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Curis, Inc.
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004487

Purpose

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.

Condition	Intervention	Phase
Vesicoureteral Reflux	Drug: chondrocyte-alginate gel suspension	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Alginic acid

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	60
Study Start Date:	May 1999

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.

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004487

Sponsors and Collaborators

FDA Office of Orphan Products Development

Curis, Inc.

Investigators

Study Chair:

Frank T. Gentile

Curis, Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004487 History of Changes
Other Study ID Numbers:	199/14267, REPRO-FDR001514, REPRO-99-07
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

rare disease
renal and genitourinary disorders
vesicoureteral reflux

Additional relevant MeSH terms:

Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases

Alginic acid
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012