Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

October 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004312 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis

Official Title ^ICMJE

Brief Summary

OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine.

II. Track and monitor all patients including renal transplant, dialysis and post renal transplants.

Detailed Description

PROTOCOL OUTLINE:

Data are collected from patients and physicians. Information includes disease, treatment, family history, demographic, and physical exam data. The dates of kidney transplantation and/or dialysis initiation are also recorded.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening

Condition ^ICMJE

Cystinosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

Nephropathic cystinosis diagnosis by white-cell cystine measurement, including infantile and late-onset forms

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00004312

Responsible Party

Study ID Numbers ^ICMJE

NCRR-M01RR00827-1196, UCSD-970026, UCSD-950338

Study Sponsor ^ICMJE

National Center for Research Resources (NCRR)

Collaborators ^ICMJE

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Diego

Investigators ^ICMJE

Study Chair:

Jerry A. Schneider

University of California, San Diego

Information Provided By

National Center for Research Resources (NCRR)

Verification Date

December 2003

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