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Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

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ClinicalTrials.gov Identifier: NCT01602835
Recruitment Status : Terminated
First Posted : May 21, 2012
Last Update Posted : February 11, 2014
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease
Alport Syndrome

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Human Urine Sample Collection for Alport Nephropathy Biomarker Studies
Study Start Date : September 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   None Retained

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with Alport syndrome identified by the Alport Syndrome Treatments and Outcome Registry (ASTOR)

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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01602835     History of Changes
Other Study ID Numbers: CPLATFRM2201
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2014

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Alport syndrome
glomerular disease
hereditary nephropathy

Additional relevant MeSH terms:
Kidney Diseases
Nephritis, Hereditary
Urologic Diseases
Urogenital Abnormalities
Congenital Abnormalities
Collagen Diseases
Connective Tissue Diseases