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

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Primary Purpose

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

chondrocyte-alginate gel suspension

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

NCT ID

NCT00004487

First Posted

October 18, 1999

Last Updated

March 24, 2015

Sponsor

FDA Office of Orphan Products Development

Collaborators

Curis, Inc.

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

Vesicoureteral Reflux

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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