Study Information
The objectives of this study are:
- to identify patients who are functionally tolerant following kidney transplantation as well as relevant groups for comparison;
- to enter demographic and clinical data from these patients into an electronic database thereby creating a registry of tolerant kidney transplant recipients in order to facilitate subsequent mechanistic studies; and
- to use cutting edge research technologies to define surrogate markers of tolerance and gain new insights into immune mechanisms underlying tolerance induction in humans.
The study will examine approximately 210 patients over 4 medical centers. Patients will be divided into eight immunologically distinct groups of kidney transplant recipients, as detailed below:
Group 1 (~50 participants) - patients who have stopped taking immunosuppressive medications for at least one year, and exhibit normal and stable kidney function.
Group 2 (~30 participants) - patients who have stopped taking immunosuppressive medications for at least one year, and have moderately impaired function or gradually deteriorating kidney function.
Group 3 (~30 participants) - patients who have discontinued taking immunosuppressive medications for at least one year, and have experienced rejection.
Group 4 (~30 participants) patients who have taken no immunosuppressive medications other than 10 mg/day of corticosteroids for at least one year, and exhibit normal and stable kidney function
Group 5 (~30 participants) - you are currently taking standard immunosuppressive medications and have stable and normal kidney allograft function after at least 1 year of receiving these drugs.
Group 6 (~30 participants) - patients who are taking standard immunosuppressive medications and are experiencing chronic rejection.
Group 7 (~5 participants) - patients who received their kidney from an identical twin.
Group 8 (undetermined) - organ donors to another individual participating in this study as a member of Groups 1, 2, 3, 4, 5 or 6.
It is hoped that a multivariate analysis of these assays will reveal a unique set of biomarkers for immune tolerance that would form the basis for a clinical assay predictive of successful weaning from immunosuppression. Additional novel information regarding the mechanisms of the creation, maintenance and loss of tolerance in human renal transplantation should also result.
Assays will be performed on both patient and donor specimens and will include cytokine snapshots, HLA-genotype, gene expression, T cell receptor diversity, dendritic cell assay and trans-vivo delayed-type hypersensitivity, as well as standard allograft biopsies. These assays will be performed in a standardized manner, many by the ITN's Core facilities.
The ITN will maintain all records and bank all clinical specimens obtained for this study, with the hope that it will eventually become a valuable resource open to the community for additional future studies of this rare cohort.
Participating Investigators
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Kenneth Newell, Emory University, Atlanta, GA |
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William Burlingham, University of Wisconsin. Madison, WI |
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Alan D. Kirk, National Institutes of Health, Bethesda, MD |
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Chris Larsen, Emory University, Atlanta, GA |
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Robert Lechler, Imperial College, UK |
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William Marks, Swedish Medical Center, Seattle, WA |
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Jean-Paul Soulillou, Nantes, France |
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Angus Thomson, University of Pittsburgh, PA |
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YOUR HELP IS NEEDED!
We are seeking kidney transplant recipients who:
> Have been off all immunosuppressive
medications for 1 year AND,
i) have good allograft function ,OR
ii) who may have impaired or gradually declining renal function (believed to be unrelated
to rejection)
> Have good allograft function on only
minimal immunosuppression (ie
corticosteroids only)
> Are recipients from identical twin
donors
If you are aware of such patients, please register to have a Registry investigator contact you for more information or call the Registry Hot-line at 1-866-752-6245.
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