Urinary Biomarkers of the Progression of Alport Kidney Disease

NCT01705132 | Completed

• 1 other identifier: 205M13905
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if there are certain laboratory tests that can be performed to detect substances or features in a child's urine that can be used to measure the progress of Alport kidney disease and the effects of treatment. These tests and their results could be of use to measure responses to new treatments in future clinical trials.

Conditions

Alport Syndrome

Outcome Measures

Primary Outcomes (1)

• Urine levels of biomarkers, corrected for urine creatinine, in Alport subjects stratified by magnitude of proteinura.

  This is a cross-sectional study. Subjects will submit a single urine sample (Day 1).

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will be comprised of male and female subjects ≥ 5 years of age, with or without existing Alport genotyping, regardless of specific genotype, and who meet all other eligibility criteria. Subjects with existing Alport genotyping are preferred. Alport subjects will be enrolled via ASTOR, and healthy volunteers will be enrolled elsewhere, outside the scope of this protocol. Approximately 80 Alport syndrome subjects will be enrolled in this study. Of the 80 subjects, 75% (N = 60) should have non-postural, non-nephrotic proteinuria (defined as spot urine protein-to-creatinine ratio \< 3 on at least 2 of the last 3 clinical assessments).

You may qualify if:

• Able to understand and comply with the requirements of the study and able to provide written informed consent.
• Male and female subjects ≥ 5 years of age.
• Physically able to provide a single first-morning urine sample of at least 30 mL (one ounce).
• Alport syndrome diagnosis: Clinical and/or histopathologic and/or genetic diagnosis of Alport Syndrome, as per the subject's physician and/or genotyping.

You may not qualify if:

• Use of investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
• Chronic kidney disease, defined as a known diagnosis of CKD, and/or 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Novartis: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• ASTOR website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Subjects submit first morning urine. Portion of urine retained for ASTOR repository.

MeSH Terms

Conditions

Nephritis, Hereditary

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nephritis; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clifford E Kashtan, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2012
• First Posted: October 12, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

US (1)