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Abstract
While immunosuppression is generally necessary for solid organ transplant recipients, evidence that not all patients require life-long immunosuppression to maintain function of the transplanted organ is found in a subset of patients who successfully discontinue immunosuppression through non-compliance or out of medical necessity and maintain normal graft function. The ALLTOL study will longitudally follow individuals who have received kidney or liver transplants and who have achieved a state of operational tolerance to their allograft.
The ALLTOL study will assess the durability of operational tolerance, the effect of allograft subtype on the maintenance of tolerance and identify potential triggers associated with the end of the tolerance period. In previous studies, gene expression signatures associated with tolerance and others predicting organ rejection have been identified. Biological samples collected as part of this study will allow for the validation of these expression patterns as well as the identification of other biomarkers associated operational tolerance. Additionally, any insights gained into these tolerance mechanisms, could provide approaches for the replication of tolerance induction in transplant recipients.
As part of this study, an electronic database of operationally tolerant allograft recipients and a repository for samples obtained from operationally tolerant allograft recipients will be created.
ALLTOL is a single-center, prospective, observational study in which operationally tolerance recipients of liver or kidney allografts will be followed longitudinally for 7 years with annual collections of clinical data and biological samples.
About This Study
For organ transplant recipients, anti-rejection medications known as “immunosuppressive drugs” help prevent the immune system from attacking the foreign organ and causing damage. Although this helps keep the organ healthy, anti-rejection medications have a number of serious side effects including an increased risk of infections and certain kinds of cancer.
Some individuals who receive organ transplants are able to come off of all immune-suppressing medications without rejecting their organ. This is called “tolerance.”
The goal of the ALLTOL Study is to follow tolerant transplant recipients to learn:
- How long liver or kidney transplant recipients can remain tolerant
- What happens in the tolerant recipient’s body over time
- If there are patterns in the body that are linked to tolerance
This study is observational, meaning there are no study medications or procedures.
Study participation will last for up to five years, and will require 1 study visit per year. These visits will include:
- Overall health assessment
- Blood and urine collections
If you cannot travel to a study site, the study site staff will discuss your health status by phone and arrange for a nurse to come to your location to collect the research specimens.
The study will run until January 31, 2021. Study participation will last for the amount of time left in the study at the time of enrollment (up to 5 years).