Genetic testing program for living kidney donors of African ancestry
Integrating a Culturally Competent APOL1 Genetic Testing Program Into Living Donor Evaluation
This study is testing a new genetic testing program for kidney donors of African ancestry to see if it helps them make better decisions and understand their health options with the help of personalized counseling and AI support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 2 sites (Washington, District of Columbia and 1 other locations) |
| Trial ID | NCT04910867 on ClinicalTrials.gov |
What this trial studies
This project aims to integrate APOL1 genetic testing into the evaluation process for living kidney donor candidates of African ancestry. It focuses on reducing decisional conflict and improving informed consent through culturally competent genetic counseling and the use of AI chatbots to provide information about APOL1 testing. The study will also incorporate APOL1 test results into electronic health records to support clinical decision-making for transplant nephrologists. By employing a hybrid effectiveness-implementation design, the study will evaluate both the effectiveness of the testing program and its implementation in clinical practice.
Who should consider this trial
Good fit: Ideal candidates are living kidney donor candidates who identify as African American or have African ancestry and are cognitively intact adults aged 18 and older.
Not a fit: Patients who do not identify as having African ancestry or are not aware of any biologically-related family with African ancestry will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance the safety and informed decision-making of living kidney donors at elevated risk of post-donation kidney failure.
How similar studies have performed: Other studies have shown success in implementing genetic testing and counseling in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Living kidney donor candidates who identify as African American/Black, Jamaican, Barbadian, Grenadian, Brazilian from Salvador Trinidadian, Panamanian, Honduran, Haitian, Garifunan, Palenque, Guyanese, Dominican, Peruvian, Belizean, and Native American, or state that they have African ancestry or are aware of having biologically-related family with African ancestry * Living kidney donor candidates may be directed or non-directed donors * Adults (ages 18+) * English-speaking * Cognitively intact individuals * All genders Exclusion Criteria: * Individuals who do not identify as African American/Black and are not aware of having any biologically-related family with African ancestry and do not have African ancestry * Only African Americans and people of African ancestry will be included because APOL1 risk variants are predominantly found in African Americans and people who have African ancestry. * Pregnant women cannot be living kidney donors
Where this trial is running
Washington, District of Columbia and 1 other locations
- Medstar Georgetown Transplant Institute — Washington, District of Columbia, United States (Recruiting)
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Elisa J Gordon — Northwestern University
- Study coordinator: Elisa J Gordon, PhD, MPH
- Email: e-gordon@northwestern.edu
- Phone: 312-503-5563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.