Genomics of Kidney Transplantation
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Purpose
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.
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.
| Condition |
|---|
|
Kidney Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- Transplant recipient genotypes: time to chronic graft disfunction [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]
- Transplant recipient genotypes: time to a persistent 25% decrease in eGFR [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]
- Transplant recipient genotypes: time to acute rejection [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]
- Transplant recipient genotypes: time to allograft failure [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]allograft failure is defined as graft loss or participant death.
- Donor Genotypes: time to chronic graft dysfunction [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: No ]The time to dysfunction of the donated organ.
- Donor Genotype: time to a persistent 25% decrease in eGFR [ Time Frame: Day 0 to year 5 ] [ Designated as safety issue: No ]The time to a persistent 25% decrease in eGFR in the donated organ's recipient.
- Donor Genotype: time to allograft failure [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: No ]The time to the failure of the donated organ (defined as graft loss or participant death).
- For recipient genotypes, time to select mycophenolate-related toxicities (leukopenia, anemia). [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]
- Recipient genotypes: time to select CNI-related toxicities [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]toxicities may include: new onset diabetes or nephrotoxicity.
- Recipient Genotypes: repeated measures of clinically obtained tacrolimus trough blood levels [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: No ]
- Recipient Candidate Genotypes: CN and IMPDH protein activity and expression. [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: No ]
- Time to composite endpoint of graft loss or death or persistent 25% increase in serum creatinine. [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- Slope of eGFR. [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: No ]
- Delayed graft function. [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]
- Time to EBV and CMV infection [ Time Frame: Day 0 to Year 5 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 4300 |
| Study Start Date: | August 2012 |
| Groups/Cohorts |
|---|
| Kidney and Kidney-Pancreas Transplant Recipients |
| Transplant Donors |
|
Activity and mRNA Expression
The Activity and mRNA Expression Cohort is a substudy cohort, and also 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 the required sample size of 600 is achieved or the protocol team terminates enrollment of the cohort. 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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
3000 Kidney or Kidney-pancreas transplant recipients and 1300 of the donors
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.
- 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 Study.
- Informed consent for participation in the Activity and mRNA Expression Cohort.
- Age 18 years or greater as of day of transplantation.
- 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.
Contacts and Locations| Contact: A Matas, MD | 612-625-6460 | matas001@umn.edu |
| United States, Alabama | |
| University of Alabama | Not yet recruiting |
| Birmingham, Alabama, United States | |
| Contact: Tina Ayer 205-996-2577 tayer@uab.edu | |
| Contact: Tena Hilario 205-996-7733 tena@uab.edu | |
| Principal Investigator: R. Mannon, MD | |
| Sub-Investigator: R. Gaston, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55414 | |
| Contact: Mandi DeGrote 612-625-1172 carl1032@umn.edu | |
| Contact: Danielle Berglund 612-624-0427 bergl175@umn.edu | |
| Principal Investigator: Arthur Matas, MD | |
| Hennepin County Medical Center | Recruiting |
| Minneapolis, Minnesota, United States, 55415 | |
| Contact: Lisa Berndt 612-347-5871 | |
| Principal Investigator: Bertram Kasiske, MD | |
| Mayo Clinic | Not yet recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Thomas DeLeeuw 507-538-8764 | |
| Principal Investigator: F. G. Cosio, MD | |
| Canada, Alberta | |
| University of Alberta | Not yet recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Susan Huygen Susan.Huygen@albertahealthservices.ca | |
| Contact: Sergey Nikitin Sergey.Nikitin@albertahealthservices.ca | |
| Principal Investigator: Sita Gourishankar, MD | |
| 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 |
More Information
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT01714440 History of Changes |
| Other Study ID Numbers: | DAIT Gen-03 |
| Study First Received: | October 17, 2012 |
| Last Updated: | October 25, 2012 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on May 21, 2013