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.
Abstract
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.
Timeline
This project is estimated to be completed by August 2023.
Workgroup Members
| Steering Committee | Christine Lee, PhD, PharmD | FDA Office of Minority Health and Health Equity |
| Steering Committee | Ogo Egbuna, MD | Vertex Pharmaceuticals |
| Steering Committee | Patrick O. Gee, Sr., PhD, JLC | KHI Patient and Family Partnership Council, APOLLO Community Advisory Committee, Evidation Health |
| Steering Committee | Susanne B. Nicholas, MD, PhD | ASN Health Care Justice Committee (Clinical Care and Innovation Team); University of California at Los Angeles |
| Steering Committee | Uptal D. Patel, MD | KHI Board of Directors, AstraZeneca |
| Steering Committee | Barbara Gillespie, MD, MS | KHI Board of Directors, Labcorp, University of North Carolina |
| Steering Committee | Glenda V. Roberts | KHI Patient and Family Partnership Council, APOLLO Community Advisory Committee, Center for Dialysis Innovation, Kidney Research Institute |
| Steering Committee | Aliza M. Thompson, MD, MS | KHI Board of Directors, FDA Center for Drug Evaluation and Research |
If you have any questions, please contact KHI at khi@asn-online.org