Genomics of Kidney Transplantation
|ClinicalTrials.gov Identifier: NCT01714440|
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : June 5, 2017
|Condition or disease|
|KidneyTransplant Recipients Simultaneous Kidney/Pancreas Recipients Kidney Transplant Donor|
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|
|Actual Enrollment :||1552 participants|
|Official Title:||Genomics of Kidney Transplantation|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
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.
- 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 Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Day 0 to Year 5 ]eGFR: Estimated GFR test results are a measure of kidney function.
- 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 ]allograft failure is defined as graft loss or participant death.
- Donor Genotypes: time to chronic graft dysfunction [ Time Frame: Day 0 to Year 5 ]The time to dysfunction of the donated organ.
- 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.
- 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).
- Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia) [ Time Frame: 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
- Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels [ Time Frame: 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
- 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-Human Leukocyte Antigen (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 Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) infection [ Time Frame: Day 0 to Year 5 ]EBV: Epstein-Barr virus. CMV: cytomegalovirus.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01714440
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55414|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|Rochester, Minnesota, United States, 55905|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Principal Investigator:||A Matas, MD||University of Minnesota - Clinical and Translational Science Institute|
|Study Chair:||A Israni, MD, MS||University of Minnesota - Clinical and Translational Science Institute|