Human Urine Sample Collection for Alport Nephropathy Biomarker Studies

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01602835
First received: May 17, 2012
Last updated: February 10, 2014
Last verified: February 2014
  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:


Further study details as provided by Novartis:

Biospecimen Retention:   None Retained

urine


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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 10, 2014
Health Authority: United States: Food and Drug Administration

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 August 28, 2014