Overview

This trial is active, not recruiting.

Conditions kidney (or simultaneous kidney-pancreas) transplant recipients, kidney transplant donor
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Genomics of Transplantation Cooperative Research Program
Start date August 2012
End date January 2017
Trial size 1552 participants
Trial identifier NCT01714440, DAIT GEN-03

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Main Study Cohort: Kidney (or kidney-pancreas) transplant recipients. Enrollment for this cohort is closed.
Main Study Cohort: The kidney donor for transplant recipients in this study. Enrollment for this cohort is closed.
**Enrollment for this subset of subjects already enrolled in the Main Study remains open at specific sites. 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 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.

Primary Outcomes

Measure
Transplant recipient genotypes: time to chronic graft disfunction
time frame: Day 0 to Year 5
Transplant recipient genotypes: time to a persistent 25% decrease in eGFR
time frame: Day 0 to Year 5
Transplant recipient genotypes: time to acute rejection
time frame: Day 0 to Year 5
Transplant recipient genotypes: time to allograft failure
time frame: Day 0 to Year 5
Donor Genotypes: time to chronic graft dysfunction
time frame: Day 0 to Year 5
Donor Genotypes: time to a persistent 25% decrease in eGFR
time frame: Day 0 to year 5
Donor Genotypes: time to allograft failure
time frame: Day 0 to Year 5
Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia)
time frame: Day 0 to Year 5
Recipient genotypes: time to select CNI-related toxicities
time frame: Day 0 to Year 5
Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels
time frame: Day 0 to Year 5
Recipient candidate genotypes: CN and IMPDH protein activity and expression
time frame: Day 0 to Year 5

Secondary Outcomes

Measure
Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine
time frame: 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-HLA antibodies, C4d positivity
time frame: Day 0 to Year 5
Slope of eGFR
time frame: Day 0 to Year 5
Delayed graft function
time frame: Day 0 to Year 5
Time to EBV and CMV infection
time frame: Day 0 to Year 5

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Genomics of Kidney Transplantation
Principal investigator A Matas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).