Genomics of Kidney Transplantation

June 2, 2017 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1552

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55414
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Transplant Recipients Cohort
Main Study Cohort: Kidney (or kidney-pancreas) transplant recipients. Enrollment for this cohort is closed.
Transplant Donors Cohort
Main Study Cohort: The kidney donor for transplant recipients in this study. Enrollment for this cohort is closed.
Activity&mRNA Expression Substudy Cohort
A 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplant recipient genotypes: time to chronic graft disfunction
Time Frame: Day 0 to Year 5
Day 0 to Year 5
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.
Day 0 to Year 5
Transplant recipient genotypes: time to acute rejection
Time Frame: Day 0 to Year 5
Day 0 to Year 5
Transplant recipient genotypes: time to allograft failure
Time Frame: Day 0 to Year 5
allograft failure is defined as graft loss or participant death.
Day 0 to Year 5
Donor Genotypes: time to chronic graft dysfunction
Time Frame: Day 0 to Year 5
The time to dysfunction of the donated organ.
Day 0 to Year 5
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.
Day 0 to year 5
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).
Day 0 to Year 5
Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia)
Time Frame: Day 0 to Year 5
Day 0 to Year 5
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
Day 0 to Year 5
Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels
Time Frame: Day 0 to Year 5
Day 0 to Year 5
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
Day 0 to Year 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine
Time Frame: Day 0 to Year 5
Day 0 to Year 5
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
Day 0 to Year 5
Slope of eGFR
Time Frame: Day 0 to Year 5
Day 0 to Year 5
Delayed graft function
Time Frame: Day 0 to Year 5
Day 0 to Year 5
Time to Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) infection
Time Frame: Day 0 to Year 5
EBV: Epstein-Barr virus. CMV: cytomegalovirus.
Day 0 to Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Genomics of Transplantation Cooperative Research Program

Investigators

  • Principal Investigator: A Matas, MD, University of Minnesota
  • Study Chair: A Israni, MD, MS, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 17, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 26, 2012

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DAIT GEN-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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