Improving kidney transplant outcomes through genetic analysis
APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
Wake Forest University Health Sciences · NCT03615235
This study is trying to see if understanding certain genetic differences in kidney donors and recipients can help improve kidney transplant success for people with African ancestry.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Locations | 18 sites (Birmingham, Alabama and 17 other locations) |
| Trial ID | NCT03615235 on ClinicalTrials.gov |
What this trial studies
The APOLLO initiative aims to enhance kidney transplantation outcomes by examining the impact of variations in the apolipoprotein L1 gene (APOL1) among kidney donors and recipients. This observational study focuses on individuals with recent African ancestry, who are at a higher risk for kidney disease due to specific genetic variants. By analyzing DNA from both living kidney donors and transplant recipients, the study seeks to understand how these genetic factors influence transplant success and donor health. The research is sponsored by the National Institutes of Health and involves multiple prominent medical institutions.
Who should consider this trial
Good fit: Ideal candidates for this study are living kidney donors with self-reported recent African ancestry.
Not a fit: Patients who do not have recent African ancestry or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney transplant outcomes and safer living kidney donation practices for individuals with specific genetic backgrounds.
How similar studies have performed: Other studies have shown promise in understanding genetic factors affecting kidney disease, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Living Donors: * Living kidney donors with self-reported recent African ancestry (defined as African American, Afro-Caribbean, Hispanic black or African) will be eligible for inclusion. Exclusion Criteria for Living Donors: * Participants who are unable or unwilling to provide informed consent. Enrollment and bio sample collection from deceased donors at OPOs ended on May 31, 2023 and recruiting kidney transplant recipients ended on June 15, 2023. Phase II started on 9/1/2023 and only Living Donors will be recruited for an additional 2 years.
Where this trial is running
Birmingham, Alabama and 17 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- University of California San Francisco — San Francisco, California, United States (RECRUITING)
- University of Miami / Miami Transplant Institute — Miami, Florida, United States (RECRUITING)
- Emory University School of Medicine — Atlanta, Georgia, United States (RECRUITING)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (RECRUITING)
- Johns Hopkins University — Baltimore, Maryland, United States (RECRUITING)
- Joslin Diabetes Center / Harvard University — Boston, Massachusetts, United States (RECRUITING)
- University of Michigan Medicine — Ann Arbor, Michigan, United States (RECRUITING)
- Saint Louis University Center for Transplantation — St Louis, Missouri, United States (RECRUITING)
- Ichan School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)
- Weill Cornell Medicine — New York, New York, United States (RECRUITING)
- Duke University — Durham, North Carolina, United States (RECRUITING)
- Wake Forest School of Medicine — Winston-Salem, North Carolina, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
- University of Wisconsin - Madison — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Barry I. Freedman, MD — Wake Forest University Health Sciences
- Study coordinator: Laurie P. Russell, MS
- Email: lrussell@wakehealth.edu
- Phone: 336-713-4292
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.
Conditions: Kidney Diseases, Kidney Failure, Kidney Disease, Chronic, Apolopoprotein L1 gene, Kidney Transplantation, Kidney Donor, United Network for Organ Sharing, Association of Organ Procurement Organizations