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NCT Number: NCT01714440

Genomics of Kidney Transplantation

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Inclusion for the Activity and mRNA Expression Cohort:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Transplant recipient genotypes: time to chronic graft disfunction

    Time frame: Day 0 to Year 5

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

    Time frame: Day 0 to Year 5

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

  3. Transplant recipient genotypes: time to acute rejection

    Time frame: Day 0 to Year 5

  4. Transplant recipient genotypes: time to allograft failure

    Time frame: Day 0 to Year 5

    allograft failure is defined as graft loss or participant death.

  5. Donor Genotypes: time to chronic graft dysfunction

    Time frame: Day 0 to Year 5

    The time to dysfunction of the donated organ.

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

    Time frame: Day 0 to year 5

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

  7. Donor Genotypes: time to allograft failure

    Time frame: Day 0 to Year 5

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

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

    Time frame: Day 0 to Year 5

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

    Time frame: Day 0 to Year 5

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

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

    Time frame: Day 0 to Year 5

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

    Time frame: Day 0 to Year 5

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

Secondary outcomes

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

    Time frame: 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

    Time frame: Day 0 to Year 5

  3. Slope of eGFR

    Time frame: Day 0 to Year 5

  4. Delayed graft function

    Time frame: Day 0 to Year 5

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

    Time frame: Day 0 to Year 5

    EBV: Epstein-Barr virus. CMV: cytomegalovirus.

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

  • Genomics of Transplantation Cooperative Research Program

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2012
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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