Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
197 participants
OBSERVATIONAL
2004-05-31
2015-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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).
No interventions assigned to this group
Group 5 - kidney standard immunotherapy
Enrollment for group 5 is closed. Stable renal transplant recipients currently on standard immunosuppression.
No interventions assigned to this group
Group 6 - kidney chronic rejector
Enrollment for group 6 is closed. Chronic allograft nephropathy group.
No interventions assigned to this group
Group 7 - kidney identical twin
Enrollment for group 7 is closed.
No interventions assigned to this group
Group 8 - living kidney donors
Corresponding to recipients in group 1 or 4.
No interventions assigned to this group
Group 9 - healthy controls
Enrollment for group 9 is closed.
No interventions assigned to this group
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).
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Meet the criteria for inclusion in one of the study enrollment groups
* Provide informed consent
Exclusion Criteria
* Current malignancy requiring recent surgery, ongoing chemotherapy or radiation
* Acute systemic infections within 30 days prior to enrollment
* Pregnancy
* Transplant of another organ
18 Years
ALL
No
Sponsors
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Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Kenneth Newell, MD, PhD
Role: STUDY_CHAIR
Emory University
Locations
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Emory University
Atlanta, Georgia, United States
NIH Clinical Center
Bethesda, Maryland, United States
Swedish Medical Center
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Schroppel B, Heeger PS. Gazing into a crystal ball to predict kidney transplant outcome. J Clin Invest. 2010 Jun;120(6):1803-6. doi: 10.1172/JCI43286. Epub 2010 May 24.
Newell KA, Asare A, Kirk AD, Gisler TD, Bourcier K, Suthanthiran M, Burlingham WJ, Marks WH, Sanz I, Lechler RI, Hernandez-Fuentes MP, Turka LA, Seyfert-Margolis VL; Immune Tolerance Network ST507 Study Group. Identification of a B cell signature associated with renal transplant tolerance in humans. J Clin Invest. 2010 Jun;120(6):1836-47. doi: 10.1172/JCI39933. Epub 2010 May 24.
Haynes LD, Jankowska-Gan E, Sheka A, Keller MR, Hernandez-Fuentes MP, Lechler RI, Seyfert-Margolis V, Turka LA, Newell KA, Burlingham WJ. Donor-specific indirect pathway analysis reveals a B-cell-independent signature which reflects outcomes in kidney transplant recipients. Am J Transplant. 2012 Mar;12(3):640-8. doi: 10.1111/j.1600-6143.2011.03869.x. Epub 2011 Dec 7.
Newell KA, Asare A, Sanz I, Wei C, Rosenberg A, Gao Z, Kanaparthi S, Asare S, Lim N, Stahly M, Howell M, Knechtle S, Kirk A, Marks WH, Kawai T, Spitzer T, Tolkoff-Rubin N, Sykes M, Sachs DH, Cosimi AB, Burlingham WJ, Phippard D, Turka LA. Longitudinal studies of a B cell-derived signature of tolerance in renal transplant recipients. Am J Transplant. 2015 Nov;15(11):2908-20. doi: 10.1111/ajt.13480. Epub 2015 Oct 13.
Yu J, Steck AK, Babu S, Yu L, Miao D, McFann K, Hutton J, Eisenbarth GS, Klingensmith G. Single nucleotide transcription factor 7-like 2 (TCF7L2) gene polymorphisms in antiislet autoantibody-negative patients at onset of diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):504-10. doi: 10.1210/jc.2007-2694. Epub 2008 Dec 2.
Brennan DC, Shannon MB, Koch MJ, Polonsky KS, Desai N, Shapiro J. Portal vein thrombosis complicating islet transplantation in a recipient with the Factor V Leiden mutation. Transplantation. 2004 Jul 15;78(1):172-3. doi: 10.1097/01.tp.0000128332.71657.ea. No abstract available.
Study Documents
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Document Type: Individual Participant Data Set
FACTOR/ITN507ST is the Study Identifier in the ITN TrialShare Clinical Trials Research Portal.
View DocumentDocument Type: Original articles w/data and reports; abstracts et al.
FACTOR/ITN507ST is the Study Identifier in the ITN TrialShare Clinical Trials Research Portal.
View DocumentRelated Links
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National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Other Identifiers
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DAIT ITN507ST
Identifier Type: -
Identifier Source: org_study_id
NCT00083655
Identifier Type: -
Identifier Source: nct_alias
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