KHI Current Project

Roadmap to Increase Disease Awareness and Clinical Trial Participation of People Carrying High-risk Genetic Variants of APOL1-associated Nephropathy

About this Project

The aim of this KHI project is to increase disease awareness, increase testing, and the participation of people carrying high-risk genetic variants causing APOL1-associated nephropathy in clinical trials.


This project will develop a roadmap that coordinates cross-sector partnerships to increase disease awareness and participation in APOL1-associated nephropathy clinical trials. Inclusivity of the entire community at-risk of APOL1-associated nephropathy, particularly those who may receive care in community health clinics, is an important principle that informs the design and utility of this project. This online resource describes a collaborative APOL-1 clinical trial engagement agenda and outlines: a) roles and key contributions of each stakeholder, b) approaches for engaging each stakeholder into an APOL1-focused collaboration, c) partnerships between stakeholder groups to support and sustain efforts that provide awareness and encourage APOL1 clinical trial participation, and c) resources that are needed for each stakeholder or can be shared by other stakeholders to strengthen outreach and engagement efforts. In addition to publishing this roadmap, the Kidney Health Initiative will continue to supplement this web-based resource by convening stakeholders on the progress, challenges, and opportunities for contributing to APOL1-associated nephropathy clinical trials. The intended audience of this web-based map includes trial sponsors, trial principal investigators, patient advisory boards, clinical care teams, community health clinics and other community organizations. It serves as a framework for other kidney clinical trial efforts that impact communities of color.


This project is estimated to be completed by August 2023.

Workgroup Members

Steering CommitteeChristine Lee, PhD, PharmD FDA Office of Minority Health and Health Equity
Steering CommitteeOgo Egbuna, MDVertex Pharmaceuticals
Steering CommitteePatrick O. Gee, Sr., PhD, JLCKHI Patient and Family Partnership Council, APOLLO Community Advisory Committee, Evidation Health
Steering CommitteeSusanne B. Nicholas, MD, PhDASN Health Care Justice Committee (Clinical Care and Innovation Team); University of California at Los Angeles
Steering CommitteeUptal D. Patel, MDKHI Board of Directors, AstraZeneca
Steering CommitteeBarbara Gillespie, MD, MSKHI Board of Directors, Labcorp, University of North Carolina
Steering CommitteeGlenda V. Roberts KHI Patient and Family Partnership Council, APOLLO Community Advisory Committee, Center for Dialysis Innovation, Kidney Research Institute
Steering CommitteeAliza M. Thompson, MD, MSKHI Board of Directors, FDA Center for Drug Evaluation and Research

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