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APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) (APOLLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03615235
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : April 11, 2022
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
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.

Condition or disease
Kidney Diseases Kidney Failure Kidney Disease, Chronic

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO)
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to death-censored renal allograft failure from the UNOS database [ Time Frame: up to 4.5 years ]
    Time from receipt of kidney transplant to death-censored renal allograft failure. Measured in days.


Secondary Outcome Measures :
  1. The rate of loss of renal clearance function from clinical laboratory data [ Time Frame: up to 4.5 years ]
    Rate of change in the estimated glomerular filtration rate Measured in ml/min/1.73 m2.

  2. The rate of change in serum creatinine concentration from clinical laboratory data [ Time Frame: up to 4.5 years ]
    Rate of change in the reciprocal of the serum creatinine concentration. Measured as 1/serum creatinine concentration [in mg/dl].

  3. Time to sustained development of overt proteinuria in the outpatient setting. [ Time Frame: up to 4.5 years ]
    Overt proteinuria is defined as urine protein:creatinine ratio (UPCR) >500 mg/g, urine albumin:creatinine ratio (UACR) >300 mg/g, or >2+ proteinuria on urine dipstick. This outcome requires repeat documentation of proteinuria using either UPCR, UACR or dipstick test >1 month after initial detection based on clinic data

  4. Rate of change in kidney function and quantitative proteinuria from baseline pre-donation levels in living kidney donors (to include effects on stages of CKD) [ Time Frame: up to 4.5 years ]
    Rate of change (i.e., slope of change) in estimated glomerular filtration rate based on serum creatinine concentration from UNOS and clinic data

  5. Renal allograft failure in patients with ESRD defined based on Standardized Outcomes in Nephrology (SONG) criteria [ Time Frame: up to 4.5 years ]
    Renal allograft failure in patients with ESRD defined based on Standardized Outcomes in Nephrology (SONG) criteria: return to chronic renal replacement therapy (dialysis for >90 days or submission of Centers for Medicare and Medicaid Services [CMS] ESRD Medical Evidence Report [2728 Form]) or repeat kidney transplantation.36 This definition of renal allograft failure specifically excludes acute kidney injury (AKI), delayed graft function (DGF), or primary non-function (requirement of dialysis for the initial 90 days after kidney transplant or re-transplant within 90 days). The diagnoses of AKI, DGF and primary non-function will be abstracted from UNOS, clinic notes and hospital discharge summaries.


Biospecimen Retention:   Samples With DNA
Whole blood for DNA extraction, serum, urine, kidney biopsy samples.

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Thirteen APOLLO Clinical Centers (CCs) will prospectively enroll eligible living kidney donors and recipients of kidney transplants from eligible living and deceased kidney donors at all transplant programs in the continental United States including Puerto Rico. The APOLLO Scientific and Data Research Center (SDRC or Coordinating Center) will support and participate in studies determining the impact of donor and recipient APOL1 genotypes on kidney transplant outcomes in recipients of a kidney transplant from a donor with recent African ancestry, and follow African ancestry living kidney donors for changes in vital status, kidney function and proteinuria. In this protocol, recent African ancestry is broadly defined as African American, Afro-Caribbean, Hispanic black, and African.
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.

Inclusion Criteria for Recipients:

  • Recipients of a kidney transplant from an eligible living or deceased donor with recent African ancestry.
  • Recipients of multi-organ transplants including a kidney plus an additional organ (i.e. liver, heart, lung, pancreas, etc.) or pediatric en bloc and dual kidney transplants.

Exclusion Criteria for Recipients:

  • Participants who are unable or unwilling to provide informed consent.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03615235


Contacts
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Contact: Laurie P. Russell, MS 336-713-4292 lrussell@wakehealth.edu
Contact: Benjamin Bagwell, BS 336-716-5777 bbagwell@wakehealth.edu

Locations
Show Show 18 study locations
Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Minority Health and Health Disparities (NIMHD)
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Barry I. Freedman, MD Wake Forest University Health Sciences
Principal Investigator: David M. Reboussin, PhD Wake Forest University Health Sciences
Study Director: Paul L. Kimmel, MD Natl Institute of Diabetes, Digestive & Kidney Diseases
Study Chair: Marva Moxey-Mims, MD Children's Natl Health System; George Washington Univ Sch of Med and Health Serv
More Information
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Publications:

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03615235    
Other Study ID Numbers: IRB00051561
U01DK116041 ( U.S. NIH Grant/Contract )
U01DK116040 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: April 11, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study participants will have the option of receiving their APOL1 genotype test result from a CLIA research lab. Deceased donor family decision makers will also have the option of receiving their loved one's APOL1 genotype test result from a CLIA research lab. Results will be made available after enrollment is complete, likely in year 3 of the study. Those who wish to receive these results will have been informed of benefits and risks of requesting and receiving this information prior to consenting to participate in APOLLO and again at the time of requesting test results. Infographics to aid in the decision process for requesting IPD are provided at the time of consent and on the APOLLO website. Prior to sending IPD, participants and deceased donor family decision makers will be asked to verify that they received and understand the information. They will be able to ask questions to local study staff or the APOLLO SDRC (Coordinating Center).
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Approximately 3 years after enrollment begins (once all testing is performed at once). Results will be available for 12 months.
Access Criteria: Requests for return of IPD will be made via the APOLLO website. Individual letters containing IPD and explanations of results will come via the USPS.
URL: http://TheApolloNetwork.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
Apolopoprotein L1 gene (APOL1)
Kidney Transplantation
Kidney Donor
 United Network for Organ Sharing (UNOS)
Association of Organ Procurement Organizations (AOPO)
Kidney Transplantation Outcomes Network
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases