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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01602835
Other study ID # CPLATFRM2201
Secondary ID
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


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals
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