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Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

This study has been terminated.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 17, 2012
Last updated: February 10, 2014
Last verified: February 2014

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.

Alport Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Biospecimen Retention:   None Retained

Enrollment: 80
Study Start Date: September 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Novartis Pharmaceuticals Identifier: NCT01602835     History of Changes
Other Study ID Numbers: CPLATFRM2201
Study First Received: May 17, 2012
Last Updated: February 10, 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 processed this record on September 20, 2017