Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

Novartis

Status: Terminated

Conditions: Alport Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT01602835

CPLATFRM2201

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

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
• Nephrotic-range proteinuria: spot urine protein-to-creatinine ratio ≥ 3 on at least 2 of the last 3 clinical assessments Other protocol-defined inclusion/exclusion criteria may apply