Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01602835

Enrollment

Registered

2012-05-21

Start date

2012-09-30

Completion date

2013-05-31

Last updated

2014-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alport Syndrome

Keywords

Alport syndrome, proteinuria, glomerular disease, hereditary nephropathy, nephropathy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

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/

Outcome results