APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
Purpose
The APOLLO study is being done in an attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.
Conditions
- Kidney Diseases
- Kidney Failure
- Kidney Disease, Chronic
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Recipients of a Kidney Transplant | APOLLO will prospectively assess transplant outcomes in recipients of kidneys from eligible living and deceased donors at all transplant programs in the United States including Puerto Rico. | |
| Living Kidney Donors | APOLLO will prospectively assess post-donation renal outcomes in eligible living kidney donors at all transplant programs in the United States including Puerto Rico. |
Recruiting Locations
Birmingham, Alabama 35233
San Francisco, California 94143
Miami, Florida 33133
Atlanta, Georgia 30322
Baltimore, Maryland 21201
Baltimore, Maryland 21205
Boston, Massachusetts 02215
Ann Arbor, Michigan 48109
Saint Louis, Missouri 63104
New York, New York 10029
New York, New York 10032
New York, New York 10065
Durham, North Carolina 27705
Winston-Salem, North Carolina 27157
Philadelphia, Pennsylvania 19104
Nashville, Tennessee 37232
Madison, Wisconsin 53792
More Details
- NCT ID
- NCT03615235
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
Detailed Description
The National Institutes of Health (NIH)-sponsored collaborative APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) is charged with prospectively assessing the effects of renal-risk variants (RRVs) in the apolipoprotein L1 gene (APOL1) on outcomes for kidneys from donors with recent African ancestry and the recipients of their kidneys, after deceased- and living-donor renal transplantation. For the purposes of APOLLO, recent African ancestry is defined as individuals with similar genetic make-up to those currently residing in Africa. APOLLO will also study the impact of APOL1 RRVs on the health of living kidney donors with recent African ancestry.