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

This study is ongoing, but not recruiting participants.

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

Sponsors and Collaborators:	FDA Office of Orphan Products Development 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

Drug Information available for: Alginic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Safety/Efficacy Study

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

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

Keywords provided by FDA Office of Orphan Products Development:

rare disease
renal and genitourinary disorders
vesicoureteral reflux

Study placed in the following topic categories:

Vesico-Ureteral Reflux
Radiation-Protective Agents
Cystocele
Alginic acid

Urologic Diseases
Urinary Bladder Diseases
Rare Diseases
Hemostatics

Additional relevant MeSH terms:

Vesico-Ureteral Reflux
Radiation-Protective Agents
Coagulants
Alginic acid
Urologic Diseases
Therapeutic Uses

Physiological Effects of Drugs
Hematologic Agents
Urinary Bladder Diseases
Protective Agents
Pharmacologic Actions
Hemostatics

ClinicalTrials.gov processed this record on May 07, 2009