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. 2024 Feb 1;19(2):202-212.
doi: 10.2215/CJN.0000000000000334. Epub 2023 Oct 23.

Participant Experience with Protocol Research Kidney Biopsies in the Kidney Precision Medicine Project

Angela M Victoria-Castro  1 , Celia P Corona-Villalobos  2 , Alan Y Xu  2 , Ingrid Onul  3 , Courtney Huynh  3 , Sarah W Chen  4 , Ugochukwu Ugwuowo  1 , Natalya Sarkisova  5 , Ashveena L Dighe  5 , Kristina N Blank  6 , Victoria M Blanc  7 , Michael P Rose  5 , Jonathan Himmelfarb  5 , Ian H de Boer  5 , Katherine R Tuttle  5 , Glenda V Roberts  5   8 ; Kidney Precision Medicine Project
Collaborators, Affiliations

Participant Experience with Protocol Research Kidney Biopsies in the Kidney Precision Medicine Project

Angela M Victoria-Castro et al. Clin J Am Soc Nephrol. .

Abstract

Background: Kidney biopsies are procedures commonly performed in clinical nephrology and are increasingly used in research. In this study, we aimed to evaluate the experiences of participants who underwent research kidney biopsies in the Kidney Precision Medicine Project (KPMP).

Methods: KPMP research participants with AKI or CKD were enrolled at nine recruitment sites in the United States between September 2019 and January 2023. At 28 days postbiopsy, participants were invited to complete a survey to share their experiences, including motivation to participate in research, comprehension of informed consent, pain and anxiety during and after the biopsy procedure, overall satisfaction with KPMP participation, and effect of the study on their lives. The survey was developed in collaboration with the KPMP Community Engagement Committee and the Institute of Translational Health Sciences at the University of Washington.

Results: One hundred and eleven participants completed the survey, 23 enrolled for AKI and 88 for CKD. The median age was 61 (interquartile range [IQR], 48-67) years, 43% were women, 28% were Black, and 18% were of Hispanic ethnicity. Survey respondents most commonly joined KPMP to help future patients (59%). The consent form was understood by 99%, and 97% recognized their important role in this study. Pain during the biopsy was reported by 50%, at a median level of 1 (IQR, 0-3) on a 0-10 scale. Anxiety during the biopsy was described by 64% at a median level of 3 (IQR, 1-5) on a 0-10 scale. More than half conveyed that KPMP participation had an effect on their diet, physical activity, and how they think about kidney disease.

Conclusions: KPMP survey respondents were most commonly motivated to participate in research protocol kidney biopsies by altruism, with excellent understanding of the informed consent process.

Podcast: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023_11_20_CJN0000000000000334.mp3This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/CJASN/2023_11_20_Spanish_CJN00000000.mp3.

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Conflict of interest statement

S.W. Chen reports employment with Brigham and Women's Hospital and Joslin Diabetes Center. C.P. Corona-Villalobos reports employment with Johns Hopkins University. I.H. de Boer reports consultancy for Alnylam, AstraZeneca, Bayer, Boehringer-Ingelheim, Boehringer-Ingelheim/Lilly, George Clinical, Gilead, Medscape, and Otsuka; research funding from DexCom and Novo Nordisk; honoraria from National Intitutes of Health; and advisory or leadership roles as a Deputy Editor of CJASN, Chair of American Heart Association Kidney in Heart Disease Science Committee, and Clinical Practice Guideline Co-Chair of Kidney Disease Improving Global Outcomes. A.L. Dighe reports ownership interest in Electronic Arts and Microsoft. J. Himmelfarb reports consultancy for Maze Therapeutics; ownership interest in Kuleana Technology, Inc.; research funding from Aurinia Pharmaceuticals; honoraria from various academic institutions for invited lectures; patents held and patents pending owned by the University of Washington; and advisory or leadership roles for BMC Medicine Editorial Board, CJASN Editorial Board, and Nature Reviews Nephrology Advisory Board; research grant support from Northwest Kidney Centers; and other interests or relationships as CEO, Founder, President, and equity holder of Kuleana Technology, Inc. G.V. Roberts is the Director of External Relations and Patient Engagement at the Kidney Research Institute and Center for Dialysis Innovation in the Division of Nephrology at the University of WA and reports ownership interest in Options Unlimited International (50%), honoraria from ProKidney, and University of Washington patent titled “Water-Conserving Kidney Dialysis System Incorporating Urea Phot-Oxidation”; advisory or leadership roles for Center for Innovations in Cancer and Transplants chair of Community Engagement (Eng.) Committee (Comm.) (CEC), CDI Patient Advisory Board, C-Path Patient Eng. Committee and DIKI Project, KHI Board of Directors, Kidney Precision Medicine Project CEC, KRI Patient Advisory Committee, LifeCenter NW Advisory Board, Expert Patient Panel for CRIC Study, and University of Minnesota’s Office of Discovery and Translation: Reduce Medication-Related Disparities in African American Patients with CKD; speakers bureau for the American Association of Kidney Patients; and other interests or relationships with American Association of Kidney Patients, APOLLO, APOLLO CAB, ASN COVID-19 Response Team and Transplant Subcommittee, ASN NTSD QAIE WG, Can-SOLVE CIRAC, CPATH BmDR Charter/Governance BioMarkers WG, HDU Advisory Committee, International Nephrology Society (ISN) Patient Group, KAC Diversity WG and Patient Education Series, KDIGO CKD and Complications in Dialysis WGs, KHI APOL1 Steering Committee, NKF Ambassador, and NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. G.V. Roberts receives honoraria from the NIH-NIDDK APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) study and the Kidney Precision Medicine Project and is supported by 2U24DK114886-06 NIH/NIDDK, R01 DK126373 NIH/NIDDK, Northwest Kidney Centers—Center for Dialysis Innovation, STUDY00014861: MRD-AA-CKD University of Minnesota. G.V. Roberts’s spouse reports consultancy for Vorsitz. K.R. Tuttle reports consultancy for AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Travere and research funding from Bayer and Travere; support by NIH research grants R01MD014712, U2CDK114886, UL1TR002319, U54DK083912, U01DK100846, OT2HL161847, and UM1AI109568 and CDC contract 75D301-21-P-12254; consultancy and speaker for Novo Nordisk; and honoraria from Bayer, Boehringer Ingelheim, and Novo Nordisk. All remaining authors have nothing to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Flow chart of survey steps and response number at 28 days. KPMP, Kidney Precision Medicine Project.
Figure 2
Figure 2
Attitudes toward informed consent and research processes.
Figure 3
Figure 3
Pain and anxiety during and after the research kidney biopsy. (A) Pain during research kidney biopsy. (B) Pain after research kidney biopsy. (C) Anxiety during research kidney biopsy. (D) Anxiety after research kidney biopsy.
Figure 4
Figure 4
Effect of KPMP participation on survey respondents.
See this image and copyright information in PMC

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