PKD Outcomes Consortium Project

This critical collaboration between the PKD Foundation, Food and Drug Administration, Critical Path Institute, clinicians and the pharmaceutical industry began in 2007 as an effort to facilitate clinical trial development for ADPKD therapies.


The PKD Outcomes Consortium Project (PKDOC) has two parts: The data standards development (CDISC - Phase I) and database development and analysis (C-Path - Phase II). Phase II  is now called the PKD Outcomes Consortium Project (PKDOC). The goal of PKDOC is to use standardized, longitudinal clinical data from PKD patients collected over a number of years in three clinical registries to provide support for the use of Total Kidney Volume (TKV) as a surrogate outcome measure in clinical trials. Glomerular filtration rate (GFR) is the current outcome measure but it remains relatively steady in PKD patients until late in the disease, making it difficult to evaluate new therapies.  An official representative from the FDA, Shona Pendse, MD, has been appointed to serve as an advisor to the project, making sure the application for use of TKV as a surrogate end point in clinical trials is as strong as possible when it’s submitted to the FDA for review and approval.

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2000 Daniel Island Drive, Charleston SC 29492
Phone: 800.443.9441 | Fax: 843.216.6100

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©2016, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.

©2016, PKD Foundation ·The PKD Foundation is a 501 (c)(3), 509 (a)(1) public charity.