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Kidney DiseaseNCT01143532

Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes

An observational study of Kidney Disease and Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. Read more about this study

Who is it for?
Ages 18 to 99 years
How many people
26 participants
Where
1 siteUnited States
Study dates
12 Aug 2010to 19 Oct 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.

Who may be able to join

  • We will study 300 African American kidney transplant dyads.
  • African descent donor and African descent recipient
  • Kidney transplant performed Jan 1995 - Dec 2006.
  • First kidney transplant
  • Kidney only transplant (excluding transplant of any other organ at any other time).

Who cannot join

  • We will exclude donors whose kidneys were used in transplants in which two organs were transplanted, e.g. pancreas and kidney, either simultaneously or at separate times. We will exclude donors whose kidneys were used in second or subsequent transplants. Rationale: dual organ transplants and serial transplants are more complicated clinical situations and renal allograft survival may be shorter and thus not comparable with other kidney transplants.
  • We will exclude recipients who had HIV, hepatitis B or hepatitis C infection diagnosed either before or after the kidney transplant.
  • Children
  • Pregnant women will be excluded but invited to participate after delivery. The rationale is the renal function is altered during pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Background:

  • Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants.
Read more

Objectives:

  • To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients.

Eligibility:

  • Participants in kidney transplant where both donor and recipient were of black African descent.
  • Eligible transplants include both living donor and deceased donor.

Design:

  • The study will involve one visit of up to 8 hours.
  • All participants will provide a detailed personal and family medical history.
  • All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing.
  • Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.
Read the detailed description

Genetic variation in the region of MYH9 and APOL1, located on chromosome 22, is a major contributor to the increased risk for kidney disease that characterizes African descent populations, although the specific gene, causative mutations, and the molecular and cellular mechanisms remain to be determined. We propose to study the role of MYH9 and APOL1 genetic variation, as well as other genes, in renal transplant, including the effect of donor genotype on recipient outcomes and on donor outcomes. Additional exploratory studies will address 1) whether variation in other donor genes might contribute to donor and recipient outcomes, which we may address with candidate gene studies or a genome-wide association study and 2) whether recipient genotype contributes to recipient outcomes, which we will address in similar ways.

MULTICENTER STUDY. We will identify 300 kidney transplant dyads (donor/recipient pairs), in which both individuals were of African descent and the kidney transplants were performed between 1995 and 2006. We will include 150 living donor transplants (selected on the basis of the ability to locate the surviving living donor and their willingness to participate) and 150 deceased donor transplants (selected at random, to minimize survival bias of the allograft). All subjects sign consents that are identical or similar to the NIH consent.

RECIPIENT OUTCOMES. We hypothesize that genetic variants in the kidney donor genome and secondarily in recipient genome might contribute to kidney recipient outcomes. We will obtain kidney donor genotypes using blood from surviving living donors or using transplant kidney biopsy DNA from now-deceased living donors, and we will obtain deceased donor genotypes by using transplant kidney biopsies. We will obtain recipient DNA, when available, from surviving recipients or from tissues obtained from deceased recipients. We will carry out Cox proportional hazards analysis to test the primary hypothesis, that donor MYH9 and APOL1 genotype influences allograft survival. We will also develop a multivariable model to predict last follow-up glomerular filtration rate, incorporating factors known to influence transplant outcomes and examining the effect of donor MYH9 and APOL1 genotype. In exploratory studies, we determine whether recipient genetic variants influence recipient outcomes.

DONOR OUTCOMES. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. While kidney donors do not have an increased risk of chronic kidney disease compared to the general population, they do have an increased prevalence of microalbuminuria. Furthermore, the extent of compensatory renal hypertrophy appears to differ among individuals. We wish to determine whether MYH9 and APOL1 genotype affects these outcomes, as well as the uncommon occurrence of overt kidney disease after kidney donation. CLINICAL IMPLICATIONS. We believe that that these studies will expand our knowledge of how donor genotypes influence kidney transplant outcomes for both donors and recipients.

COLLABORATIVE STUDY. In separate but related studies, we will work with various collaborators who pursuing similar question under research protocols that they have generated and for which they have local IRB approvals. We will receive from these collaborators materials for preparation of DNA, from which we will genotype APOL1 and other genes known or hypothesized to be related to donor and recipient transplant outcomes.

Keywords
African-Americans, MYH9, Chronic Allograft Nephropathy, Chronic Kidney Disease, Proteinuria, Natural History, Kidney Disease, Kidney Transplant, African-American
Medical subject headings
Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01143532
Study groupRoleWhat they receive
Kidney transplant donor of black African descent.Kidney transplant donor of black African descent.
Kidney transplant recipient of black African descentKidney transplant recipient of black African descent.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whether variation in other donor genes might contribute to donor and recipient outcomes

    Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.

    Measured: 1995-2006

Secondary outcomes (1)
  1. Whether recipient genotype contributes to recipient outcomes.

    We hypothesize that genetic variants in the kidney donor genome and secondarily in recipient genome might contribute to kidney recipient outcomes.

    Measured: 1995-2006

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2010 (estimated)
  2. Study start12 Aug 2010
  3. Primary completion19 Oct 2015
  4. Study completion19 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01143532
Sponsor's protocol ID
100135
Other IDs
10-DK-0135
Status last verified
Feb 2023
First submitted
11 Jun 2010
Last updated
24 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Disease and Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whether variation in other donor genes might contribute to donor and recipient outcomes (time frame: 1995-2006). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.

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