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KidneyTransplant RecipientsNCT01714440

Genomics of Kidney Transplantation

An observational study of KidneyTransplant Recipients and Simultaneous Kidney/Pancreas Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.

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

The major aim of this research study is to investigate the relationship between genetic variation in DNA (inherited code material in the cells of the body) and factors affecting transplant outcomes, like the drugs people receive or the way their immune systems work, for example. Read more about this study

Who is it for?
Any age
How many people
1,552 participants
Where
5 sitesin 2 countries
Study dates
Aug 2012to Jan 2017
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Targeted: 3000 Kidney or Kidney-pancreas transplant recipients and 1300 of the donors

Who may be able to join

  • Kidney (or kidney-pancreas) transplant recipient no more than 10 days post-transplant or kidney donor no more than 30 days post-transplant or previously enrolled in Phase I of the Genomics of Kidney Transplantation Study;
  • No organs other than kidney or pancreas transplanted simultaneously with the qualifying kidney transplant; and
  • Participant or parent/guardian must be able to understand and provide written informed consent.
  • Recipient enrolled in the Main Cohort Study;
  • Informed consent for participation in the Activity and mRNA Expression Cohort;
  • Age 18 years or greater as of day of transplantation;and
  • Will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy.

Who cannot join

  • Inability or unwillingness of the participant or parent/guardian to give a written informed consent or comply with the study protocol.
  • For the Activity and mRNA Expression Cohort:
  • Inability or unwillingness of the participant or parent/guardian to give a written informed consent for participation in the Activity and mRNA Expression Cohort or comply with the study protocol.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • University of Alabama

    Birmingham, Alabama, 35294

  • University of Minnesota

    Minneapolis, Minnesota, 55414

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

The major aim of this research study is to investigate the relationship between genetic variation in DNA (inherited code material in the cells of the body) and factors affecting transplant outcomes, like the drugs people receive or the way their immune systems work, for example. To do this, investigators will collect blood samples from participants. Genetic material will be separated from each blood sample and analyzed, looking for genetic variation.

Read the detailed description

In the past, the major problems in kidney transplantation were surgical complications, acute rejection, and infections. Right now, researchers are focusing on improving immune suppression therapy and achieving better long-term survival of kidney transplants. One of the ways to try to understand what causes loss of function after many years is to find out if there is a genetic factor involved.

There are a number of differences in specific genes that have been identified and are thought to affect transplant outcomes. Studying these gene variations (differences between people or differences between populations) is important in determining whether these variations are related to transplant outcomes and how this information can help patients achieve better long-term transplant survival.

Keywords
genomics of kidney transplantation, genetic variation, recipient genotypes, donor genotypes

What participants receive

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

Study groups in NCT01714440
Study groupRoleWhat they receive
Transplant Recipients CohortMain Study Cohort: Kidney (or kidney-pancreas) transplant recipients. Enrollment for this cohort is closed.
Transplant Donors CohortMain Study Cohort: The kidney donor for transplant recipients in this study. Enrollment for this cohort is closed.
Activity&mRNA Expression Substudy CohortA subset of subjects enrolled in the main study who will receive tacrolimus, cyclosporine or mycophenolate as part of maintenance immunosuppression therapy. This group has a prospective observational cohort design. Enrollment into the Activity and messenger ribonucleic acid (mRNA) Expression Cohort, occurring concurrently with enrollment of the rest of the study, will continue until either the required sample size of 600 is achieved or the protocol team terminates enrollment. Participants in the Activity and mRNA Expression Cohort have additional blood draws up to 2 weeks prior to transplant, at week 1, Month 3 and Month 6 post-transplant.

What is being measured

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

  1. Transplant recipient genotypes: time to chronic graft disfunction

    Measured: Day 0 to Year 5

  2. Transplant recipient genotypes: time to a persistent 25% decrease in Estimated Glomerular Filtration Rate (eGFR)

    eGFR: Estimated GFR test results are a measure of kidney function.

    Measured: Day 0 to Year 5

  3. Transplant recipient genotypes: time to acute rejection

    Measured: Day 0 to Year 5

  4. Transplant recipient genotypes: time to allograft failure

    allograft failure is defined as graft loss or participant death.

    Measured: Day 0 to Year 5

  5. Donor Genotypes: time to chronic graft dysfunction

    The time to dysfunction of the donated organ.

    Measured: Day 0 to Year 5

  6. Donor Genotypes: time to a persistent 25% decrease in eGFR

    The time to a persistent 25% decrease in eGFR in the donated organ's recipient.

    Measured: Day 0 to year 5

  7. Donor Genotypes: time to allograft failure

    The time to the failure of the donated organ (defined as graft loss or participant death).

    Measured: Day 0 to Year 5

  8. Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia)

    Measured: Day 0 to Year 5

  9. Recipient genotypes: time to select Calcineurin Inhibitor (CNI)-related toxicities

    Toxicities may include: new onset diabetes or nephrotoxicity. CNI: calcineurin inhibitor

    Measured: Day 0 to Year 5

  10. Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels

    Measured: Day 0 to Year 5

  11. Recipient candidate genotypes: Calcineurin (CN) and IMPDH protein activity and expression

    CN: Calcineurin. IMPDH: Inosine-5'-monophosphate dehydrogenase

    Measured: Day 0 to Year 5

Secondary outcomes (5)

  1. Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine

    Measured: Day 0 to Year 5

  2. Time to renal biopsy with presence of the following semi-quantitative pathology endpoints: patterns of Banff biopsy score, presence of circulating anti-donor anti-Human Leukocyte Antigen (HLA) antibodies, C4d positivity

    Measured: Day 0 to Year 5

  3. Slope of eGFR

    Measured: Day 0 to Year 5

  4. Delayed graft function

    Measured: Day 0 to Year 5

  5. Time to Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) infection

    EBV: Epstein-Barr virus. CMV: cytomegalovirus.

    Measured: Day 0 to Year 5

Timeline

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

  1. First posted26 Oct 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2017
  4. Study completionJan 2017

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
Prospective
Enrolment
1,552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01714440
Sponsor's protocol ID
DAIT GEN-03
Status last verified
Jun 2017
First submitted
17 Oct 2012
Last updated
5 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Cao R, Schladt DP, Dorr C, Matas AJ, Oetting WS, Jacobson PA, Israni A, Chen J, Guan W. Polygenic risk score for acute rejection based on donor-recipient non-HLA genotype mismatch. PLoS One. 2024 May 31;19(5):e0303446. doi: 10.1371/journal.pone.0303446. eCollection 2024.

    PubMed 38820342

  • Nguyen TT, Pearson RA, Mohamed ME, Schladt DP, Berglund D, Rivers Z, Skaar DJ, Wu B, Guan W, van Setten J, Keating BJ, Dorr C, Remmel RP, Matas AJ, Mannon RB, Israni AK, Oetting WS, Jacobson PA. Pharmacogenomics in kidney transplant recipients and potential for integration into practice. J Clin Pharm Ther. 2020 Dec;45(6):1457-1465. doi: 10.1111/jcpt.13223. Epub 2020 Jul 14.

    PubMed 32662547

  • Oetting WS, Schladt DP, Dorr CR, Wu B, Guan W, Remmel RP, Ikle D, Mannon RB, Matas AJ, Israni AK, Jacobson PA; DeKAF Genomics and GEN03 Investigators. Analysis of 75 Candidate SNPs Associated With Acute Rejection in Kidney Transplant Recipients: Validation of rs2910164 in MicroRNA MIR146A. Transplantation. 2019 Aug;103(8):1591-1602. doi: 10.1097/TP.0000000000002659.

    PubMed 30801535

Questions about this trial

What is this clinical trial studying?

An observational study of KidneyTransplant Recipients and Simultaneous Kidney/Pancreas Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in 2 countries.

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 7 inclusion and 3 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 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. 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?

Transplant recipient genotypes: time to chronic graft disfunction (time frame: Day 0 to Year 5). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01714440, which also lists 3 linked publications.

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 5 Jun 2017.

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