Clinical Trial: Urine, DNA and Clinical Information Collection From Patients With Alport Nephropathy.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Urine, DNA and Retrospective Clinical Information Collection From Patients With Alport Nephropathy.

Brief Summary: This biomarker study is a follow-up to CPLATFRM2201. The goal of CBASICHR0005 is to collect another urine sample, interval clinical information, and an optional DNA sample from as many of the original 80 patients as possible. This new information will transform the data obtained in PLATFRM2201 from a cross-section to a temporal profile, which will (a) further enable the identification of biomarkers predictive of faster progression, and (b) satisfy the FDA's recommendation to perform "natural history studies" in rare diseases.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Urine levels of biomarkers - corrected for urine creatinine [ Time Frame: Day 1 ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Urine level of biomarkers - corrected for urine creatinine [ Time Frame: Day 1 ]

Urine levels of biomarkers, corrected for urine creatinine, in healthy subjects.


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: February 23, 2017
Date Started: April 30, 2017
Date Completion: November 15, 2017
Last Updated: April 21, 2017
Last Verified: April 2017