Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

NCT01602835 | Terminated DMC

• 1 other identifier: CPLATFRM2201
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Keywords

Alport syndrome; proteinuria; glomerular disease; hereditary nephropathy; nephropathy

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with Alport syndrome identified by the Alport Syndrome Treatments and Outcome Registry (ASTOR)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Biospecimen

Retention: NONE RETAINED

urine

MeSH Terms

Conditions

Nephritis, Hereditary; Proteinuria; Kidney Diseases

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nephritis; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: May 21, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: February 11, 2014

Record last verified: 2014-02