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

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

ArmDescriptionAssigned 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

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Katherine Basinger, RN
205-934-0035
katherinemiller@uabmc.edu

University of California San Francisco
San Francisco, California 94143
Contact:
Farshad Palad
415-476-8695
farshad.palad@ucsf.edu

University of Miami / Miami Transplant Institute
Miami, Florida 33133
Contact:
Lissett Tueros
305-355-5315
ltueros@med.miami.edu

Emory University School of Medicine
Atlanta, Georgia 30322
Contact:
Elizabeth Ferry
404-712-1816
elizabeth.ferry@emoryhealthcare.org

University of Maryland School of Medicine
Baltimore, Maryland 21201
Contact:
Amanda Bartosic
410-328-0303
abartosic@som.umaryland.edu

Johns Hopkins University
Baltimore, Maryland 21205
Contact:
Darin Ostrander, PhD
410-614-6702
dostran1@jhmi.edu

Joslin Diabetes Center / Harvard University
Boston, Massachusetts 02215
Contact:
Camille Johansen, M.S.
617-309-4130
camille.johansen@joslin.harvard.edu

University of Michigan Medicine
Ann Arbor, Michigan 48109
Contact:
Jennifer Czerr
216-444-3256
czerrj@ccf.org

Saint Louis University Center for Transplantation
Saint Louis, Missouri 63104
Contact:
Kathryn Lindsay, MSN, APRN
314-577-8460
kathryn.lindsay@health.slu.edu

Ichan School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Brandy Haydel
212-241-0255
brandy.haydel@mountsinai.org

Columbia University Irving Medical Center
New York, New York 10032
Contact:
Miah Li
212-305-8392
mtl2156@cumc.columbia.edu

Weill Cornell Medicine
New York, New York 10065
Contact:
Gabriel Stryjniak
212-746-2377
gas2014@med.cornell.edu

Duke University
Durham, North Carolina 27705
Contact:
Lynnette Moats
919-681-3399
lynnette.moats@duke.edu

Wake Forest School of Medicine
Winston-Salem, North Carolina 27157
Contact:
Benjamin Bagwell, BS
336-716-5777
bbagwell@wakehealth.edu

Cleveland Clinic
Cleveland, Ohio 44106
Contact:
Jennifer Czerr
216-444-3256
czerrj@ccf.org

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Miah Li
212-305-8392
mtl2156@cumc.columbia.edu

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Brigitta Brannon
615-343-1218
brigitta.brannon@vumc.org

University of Wisconsin - Madison
Madison, Wisconsin 53792
Contact:
Lucy Ptak
608-262-0731
ldptak@medicine.wisc.edu

More Details

NCT ID
NCT03615235
Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

Laurie P. Russell, MS
336-713-4292
lrussell@wakehealth.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.