Study of Tolerant Kidney Transplant Recipients (FACTOR)
The purpose of this multi-center (observational) registry study is to establish a database of clinical and laboratory information that may help to identify any unique characteristics of tolerant participants that differ from participants who reject their kidney after discontinuing immunosuppressive drugs.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Identification and Mechanistic Investigations of Tolerant Transplant Recipients|
- To identify individuals who have received a kidney transplant and who have achieved a state of immune tolerance to graft [ Time Frame: 0 to 11 years ] [ Designated as safety issue: No ]
- To create an electronic registry of data on the tolerant and comparison groups that will serve as the basis for statistical analyses [ Time Frame: 0 to 11 years ] [ Designated as safety issue: No ]
- To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance [ Time Frame: 0 to 11 years ] [ Designated as safety issue: No ]
- To use data from the registry to create and assess predictive statistical models to model such variables as clinical features, duration of tolerant state, and time to onset of immune sensitization [ Time Frame: 0 to 11 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood, urine and tissue samples
|Study Start Date:||May 2004|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Group 1 - kidney tolerant
Renal allograft recipients showing functional tolerance (normal and stable renal function) after discontinuation of immunosuppressive medications for at least 1 year (or based on the investigator's discretion).
Group 2 - acceptor
Enrollment for group 2 was closed. Renal transplant recipients with functioning allografts (not on dialysis) who had not received immunosuppressive medications for at least 1 year (or at investigator's discretion) but who had moderately impaired or gradually deteriorating renal function, defined as creatinine clearance (CrCl) < 40 mL/min and/or creatinine > 50% above baseline value, and thus did not qualify for group 1.
Group 3 - kidney graft loss
Enrollment for group 3 is closed. These were renal transplant recipients who had subsequently rejected and lost function of their transplanted kidney.
Group 4 - kidney monotherapy
Renal transplant recipients showing stable and normal renal function after receiving only prednisone 10 mg/day for at least 1 year (or based on the investigator's discretion).
Group 5 - kidney standard immunotherapy
Enrollment for group 5 is closed. Stable renal transplant recipients currently on standard immunosuppression.
Group 6 - kidney chronic rejector
Enrollment for group 6 is closed. Chronic allograft nephropathy group.
Group 7 - kidney identical twin
Enrollment for group 7 is closed.
Group 8 - living kidney donors
Corresponding to recipients in group 1 or 4.
Group 9 - healthy controls
Enrollment for group 9 is closed.
Group 10 - liver tolerant
Enrollment for group 10 is closed. Liver allograft recipients with functional tolerance (stable and normal liver function) after cessation of immunosuppressive medications for at least three years (or at investigator's discretion).
Group 11 - liver standard immunotherapy
Enrollment for group 11 is closed. Subjects with a liver transplant who never had an attempt made to discontinue gradually their immunosuppression and who are currently taking standard immunosuppressive medications and have stable and normal liver allograft function after at least 1 year of receiving these drugs.
Following kidney (renal) transplantation, one possible complication is rejection of the new kidney. This occurs as a results of the body's immune system attacking (or rejecting) the newly transplanted kidney. After transplant, medicines known as "immunosuppressive" or "anti-rejection" drugs are given to transplant recipients to help prevent rejection of the transplanted kidney. If a transplant recipient stops taking these medicines, they almost always reject their transplanted kidney. However, in some exceptionally rare instances, transplant recipients who stop taking these drugs do not reject their kidney, and the kidney keeps working. The recipients are said at that point to "tolerate" the transplanted kidney, and this condition is referred to as "tolerance".
In this study, participants will be asked to provide consent for the collection of extensive demographic and clinical information; medical histories; and blood and urine samples. Blood and urine samples collected will be used to perform specific assays to help define mechanisms of tolerance.
Originally the study included 11 groups as listed; however, at present only groups 1,4, and 8 remain active. Whereas the initial study duration was 6 years, this was extended to 11 years in order to follow over more extended time a B cell signature identified for tolerant kidney subjects and how this signature may change. (Refer to publications section: Newell, Kirk et al, J Clin Invest. 2010).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338779
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|NIH Clinical Center|
|Bethesda, Maryland, United States, 20814|
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98104|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Kenneth Newell, MD, PhD||Emory University|