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Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

This study is not yet open for participant recruitment.
Verified May 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01602835
First received: May 17, 2012
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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
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:

U.S. FDA Resources

Further study details as provided by Novartis:

Biospecimen Retention:   None Retained

urine


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

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
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)

Criteria

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01602835     History of Changes
Other Study ID Numbers: CPLATFRM2201
Study First Received: May 17, 2012
Last Updated: May 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Alport syndrome
proteinuria
glomerular disease
hereditary nephropathy
nephropathy

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

ClinicalTrials.gov processed this record on May 23, 2013