Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

NCT ID: NCT01602835

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-05-31

Brief Summary

This is a prospective cross-sectional, observational, single-center study of Alport patients, in which a single, first morning voided urine collection will be acquired and used to validate assays of urine biomarkers that reflect changes in glomerular protein filtration barrier function.

The purpose of this study is to identify biomarkers indicative of changes in glomerular filtration function that occur during the course of proteinuric renal diseases such as Alport nephropathy.

Conditions

Alport Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Alport syndrome diagnosis (clinical and/or histopathologic and/or genetic diagnosis, per subject's physician and/or genotyping)
• Physically able to provide a single first-morning urine sample of at least 30 mL

Exclusion Criteria

• Diagnosis of chronic kidney disease
• Receiving chronic phosphate-lowering therapy or erythropoietin therapy
• Ongoing chronic hemodialysis therapy and/or renal transplant recipient

• Minimum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CPLATFRM2201

Identifier Type: -

Identifier Source: org_study_id