Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

Alport Syndrome Clinical Trial

Official title:

Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01602835
• Other study ID #: CPLATFRM2201
• Status: Terminated
• Phase: N/A
• First received: May 17, 2012
• Last updated: February 10, 2014
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alport Syndrome
• Kidney Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals