Kidney Transplant Donor Clinical Trial
Official title:
Genomics of Kidney Transplantation
| Verified date | June 2017 |
| Source | National Institute of Allergy and Infectious Diseases (NIAID) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1552 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Alberta | Edmonton | Alberta |
| United States | University of Alabama | Birmingham | Alabama |
| United States | Hennepin County Medical Center | Minneapolis | Minnesota |
| United States | University of Minnesota | Minneapolis | Minnesota |
| United States | Mayo Clinic | Rochester | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Genomics of Transplantation Cooperative Research Program |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Transplant recipient genotypes: time to chronic graft disfunction | Day 0 to Year 5 | ||
| Primary | Transplant recipient genotypes: time to a persistent 25% decrease in Estimated Glomerular Filtration Rate (eGFR) | eGFR: Estimated GFR test results are a measure of kidney function. | Day 0 to Year 5 | |
| Primary | Transplant recipient genotypes: time to acute rejection | Day 0 to Year 5 | ||
| Primary | Transplant recipient genotypes: time to allograft failure | allograft failure is defined as graft loss or participant death. | Day 0 to Year 5 | |
| Primary | Donor Genotypes: time to chronic graft dysfunction | The time to dysfunction of the donated organ. | Day 0 to Year 5 | |
| Primary | Donor Genotypes: time to a persistent 25% decrease in eGFR | The time to a persistent 25% decrease in eGFR in the donated organ's recipient. | Day 0 to year 5 | |
| Primary | Donor Genotypes: time to allograft failure | The time to the failure of the donated organ (defined as graft loss or participant death). | Day 0 to Year 5 | |
| Primary | Recipient genotypes: time to select mycophenolate-related toxicities (leukopenia, anemia) | Day 0 to Year 5 | ||
| Primary | Recipient genotypes: time to select Calcineurin Inhibitor (CNI)-related toxicities | Toxicities may include: new onset diabetes or nephrotoxicity. CNI: calcineurin inhibitor | Day 0 to Year 5 | |
| Primary | Recipient genotypes: repeated measures of clinically obtained tacrolimus trough blood levels | Day 0 to Year 5 | ||
| Primary | Recipient candidate genotypes: Calcineurin (CN) and IMPDH protein activity and expression | CN: Calcineurin. IMPDH: Inosine-5'-monophosphate dehydrogenase | Day 0 to Year 5 | |
| Secondary | Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine | Day 0 to Year 5 | ||
| Secondary | 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 | Day 0 to Year 5 | ||
| Secondary | Slope of eGFR | Day 0 to Year 5 | ||
| Secondary | Delayed graft function | Day 0 to Year 5 | ||
| Secondary | Time to Epstein-Barr virus (EBV) and Cytomegalovirus (CMV) infection | EBV: Epstein-Barr virus. CMV: cytomegalovirus. | Day 0 to Year 5 |
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