NCT04910867

APOL1 Genetic Testing Program for Living Donors

Active, enrolled NA Last updated 25 July 2025

What this trial tests

NA trial testing Components of Genetic Counseling in Chronic Kidney Diseases in 206 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

9 September 2021

Primary endpoint
31 March 2026

31 March 2026

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	health services research
Enrollment	206
Start date	9 September 2021
Primary completion	31 March 2026
Estimated completion	31 March 2026
Sites	2 locations across United States

Drugs / interventions tested

• Components of Genetic Counseling
• APOL1 genetic testing
• EHR integration

Conditions studied

• Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
• Apolipoprotein L1 — all drugs for Apolipoprotein L1 →
• Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Northwestern University

Who can join

18 and older, any sex, with Chronic Kidney Diseases or Apolipoprotein L1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Living donor (LD) kidney transplantation is the optimal treatment for patients with end-stage kidney disease (ESKD). However, LDs take on a higher risk of future ESKD themselves. African American (AA) LDs have an even greater, 3.3-fold, risk of ESKD than white LDs post-donation. Because evidence suggests that Apolipoprotein L1 (APOL1) risk variants contribute to this greater risk, transplant nephrologists are increasingly using APOL1 testing to evaluate LD candidates of African ancestry. However, nephrologists do not consistently perform genetic counseling with LD candidates about APOL1 due to a lack of knowledge and skill in counseling about APOL1. Without proper counseling, APOL1 testing will magnify LD candidates' decisional conflict about donating, jeopardizing their informed consent. Given their elevated risk of ESRD post-donation, and AAs' widely-held cultural concerns about genetic testing, it is ethically critical to protect AA LD candidates' safety through APOL1 testing in a culturally competent manner to improve informed decisions about donating.

No transplant programs have integrated APOL1 testing into LD evaluation in a culturally competent manner. Clinical "chatbots," mobile apps that use artificial intelligence to provide genetic information to patients and relieve constraints on clinicians' time, can improve informed treatment decisions and reduce decisional conflict. The chatbot "Gia," created by a medical genetics company, can be adapted to any condition. However, no chatbot on APOL1 is currently available. No counseling training programs are available for nephrologists to counsel AA LDs about APOL1 and donation in a culturally competent manner. Given the shortage of genetic counselors, increasing nephrologists' genetic literacy is critical to integrating genetic testing into practice.

The objective of this study is to culturally adapt and evaluate the effectiveness of an APOL1 testing program for AA LDs at two transplant centers serving large AA LD populations (Chicago, IL, and Washington, DC). The APOL1 testing program will evaluate the effect of the culturally competent testing, chatbot, and counseling on AA LD candidates' decisional conflict about donating, preparedness for decision-making, willingness to donate, and satisfaction with informed consent. The specific aims are to:

1. Adapt Gia and transplant counseling to APOL1 for use in routine clinical practice
2. Evaluate the effectiveness of this intervention on decisional conflict, preparedness, and willingness to donate in a pre-post design
3. Evaluate the implementation of this intervention into clinical practice by using the RE-AIM framework to longitudinally evaluate nephrologist counseling practices and LDs' satisfaction with informed consent.

The impact of this study will be the creation of a model for APOL1 testing of AA LDs, which can then be implemented nationally via implementation science approaches. APOL1 will serve as a model for integrating culturally competent genetic testing into transplant and other practices to improve patient informed consent.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Use of 'Omics for Diagnosing and Predicting Progression of Chronic Kidney Disease: A Scoping Review.
   Govender MA, Brandenburg JT, Fabian J, Ramsay M. · · 2021 · cited 23× · PMID 34819944 · DOI 10.3389/fgene.2021.682929
2. Implementation of a culturally competent <i>APOL1</i> genetic testing programme into living donor evaluation: A two-site, non-randomised, pre-post trial design.
   Smith JD, Agrawal A, Wicklund C, Duquette D, et al · · 2023 · cited 12× · PMID 37188469 · DOI 10.1136/bmjopen-2022-067657
3. FSGS Recurrence Collaboration: Report of a Symposium.
   Gipson DS, Wang CS, Salmon E, Gbadegesin R, et al · · 2024 · cited 7× · PMID 38348154 · DOI 10.1159/000535138
4. Transplant Nephrologists' Preferences for Clinical Decision Support for APOL1 Genetic Testing of Living Kidney Donors: A Focus Group Study.
   Rasmussen LV, Agrawal AH, Gordon EJ. · · 2023 · cited 2× · PMID 38032814 · DOI 10.34067/kid.0000000000000265
5. Strategies for choosing the best living donor: A review of the literature and a proposal of a decision-making paradigm.
   Charnaya O, Van Arendonk K, Segev DL. · · 2024 · cited 1× · PMID 38766997 · DOI 10.1111/petr.14779
6. Apolipoprotein L1 Genetic Testing and Counseling Does Not Reduce Living Kidney Donors' Willingness to Donate : A Hybrid Type 2 Nonrandomized Controlled Trial.
   Gordon EJ, Gacki-Smith J, Smith JD, Wicklund C, et al · · 2026 · PMID 42008800 · DOI 10.2215/cjn.0000001064
7. Contextual factors of implementing APOL1 genetic testing into living kidney donor clinical evaluation.
   Merle JL, Kuo MC, Gacki-Smith J, Agrawal A, et al · · 2025 · PMID 40498120 · DOI 10.1007/s00103-025-04068-8