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KidneyTransplant Recipients | Genomics of Kidney Transplantation

KidneyTransplant Recipients research study

What is the primary objective of 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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

KidneyTransplant Recipients

Simultaneous Kidney/Pancreas Recipients

Kidney Transplant Donor

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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.

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.

Study Status

Completed

Start Date: August 2012

Completed Date: January 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Transplant recipient genotypes: time to chronic graft disfunction

Secondary Outcome: Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine

Study sponsors, principal investigator, and references

Principal Investigator: A Matas, MD

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator: Genomics of Transplantation Cooperative Research Program

More information:https://clinicaltrials.gov/show/NCT01714440

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