Kidney Health Initiative Announces Pilot Projects, Leadership

ASN and FDA launched the Kidney Health Initiative (KHI), a new public-private partnership in September 2012. In less than one year, KHI has made significant progress moving the partnership forward.

The Board of Directors for KHI was appointed in February 2013 (Table 1). Members of the Board of Directors were selected from the initiative’s Pioneer Members. An important strength of the Board is that it represents the richly diverse interests of stakeholders. The Board met by conference call twice prior to hosting its first face-to-face meeting on May 8, 2013. Topics discussed at these first meetings have included defining key mission areas for KHI, identifying topics for KHI to address, and building a collaborative project submission process for KHI members to submit their concepts.

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To date, the response to KHI from the nephrology community has been overwhelmingly positive. Membership has currently surpassed 40 Pioneer Members and includes patients, health professionals, and research institutes as well as the biotechnology, dialysis, medical device, and pharmaceutical industries from the United States and abroad. To view a complete and updated list of members, please visit the KHI website (http://www.kidneyhealthinitiative.org).

While the infrastructure of KHI was being established, the leadership identified and initiated two pilot projects with the hope that these pilot projects will serve as examples of the strength of KHI and a model for future proposals. A pilot project on pharmacokinetics in patients receiving continuous renal replacement therapy (CRRT) is underway and is being led by co-chairs George R. Aronoff, MD, FACP, and Thomas D. Nolin PhD, PharmD, FASN. The objective is to improve the process of studying drug dosing in CRRT patients. The workgroup will generate a white paper that will concisely report on multiple considerations in performing pharmacokinetics studies in CRRT patients.

Brad H. Rovin, MD, FASN. is leading the second pilot project examining clinical trial endpoints in lupus nephritis. This project is a partnership with the Lupus Nephritis Trial Network (LNTN) and includes both nephrologists and rheumatologists focused on treating lupus nephritis. The project has three components: a comprehensive literature review to identify lupus nephritis outcome measures currently and previously used, an analysis of primary data from completed clinical trials and observational databases, and the derivation of consensus recommendations.

The study group will recommend a core set of outcome measures, biomarkers, surrogate markers, and clearly defined terms that should be incorporated into all lupus nephritis trials such that these trials represent best practices in this area. By establishing a core set of measures, this work will also provide a basis for comparison of results across future trials.

The final pilot project initiated by KHI members will be a white paper aimed at identifying barriers to innovation in kidney disease. For more information on the pilot projects or publications, please visit the KHI website (http://www.kidneyhealthinitiative.org).

Starting this summer, KHI will begin accepting ideas for projects from its members, which is its main focus. In September, members of KHI will come together for an annual stakeholder’s meeting. This conference is intended to help KHI members discuss ongoing projects, identify new projects for collaboration, and learn more about the linkages and collaborations between the renal community and the FDA.

KHI looks forward to updating the nephrology community as ongoing and future projects generate important data for the continued scientific advancement of patients with kidney disease.

To learn more about KHI, pilot projects, or membership, please visit http://www.kidneyhealthinitiative.org, or contact KHI Project Director Melissa West at mwest@asn-online.org.

July 2013 (Vol. 5, Number 7)