Study of Tolerant Kidney Transplant Recipients

Kidney Transplantation Clinical Trial

— FACTOR  

Official title:

Identification and Mechanistic Investigations of Tolerant Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338779
• Other study ID #: DAIT ITN507ST
• Status: Completed
• Phase: N/A
• First received: April 18, 2011
• Last updated: September 29, 2016
• Start date: May 2004
• Est. completion date: August 2015

Study information

• Verified date: September 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Other known NCT identifiers

• NCT00083655

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must be a renal transplant recipient or living donor

• Meet the criteria for inclusion in one of the study enrollment groups

• Provide informed consent

Exclusion Criteria:

• AIDS [includes all HIV-infected persons who have less than 200 cells/mm(3) CD4+ T-lymphocytes/microL, or a CD4+ T-lymphocyte/micro liter or a CD4+ T-lymphocyte percent of total lymphocytes less than 14, or who have been diagnosed with an AIDS-defining condition as defined by the Centers for Disease Control and Prevention (CDC)

• Current malignancy requiring recent surgery, ongoing chemotherapy or radiation

• Acute systemic infections within 30 days prior to enrollment

• Pregnancy

• Transplant of another organ

Note: Patients meeting any of the exclusion criteria, if identified to have been clinically tolerant prior to the occurrence of the excluding condition, will be enrolled and demographic data collected for the registry; however, the decision as to whether or not to collect blood, urine, and tissue samples will be deferred until the participant's condition improves and the clinically tolerant state persists.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation
• Renal Transplant
• Renal Transplantation
• Transplant Rejection
• Transplant Tolerance

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	NIH Clinical Center	Bethesda	Maryland
United States	University of Wisconsin	Madison	Wisconsin
United States	Swedish Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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 tra — View Citation

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 associat — View Citation

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 stu — View Citation

Schröppel 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify individuals who have received a kidney transplant and who have achieved a state of immune tolerance to graft		0 to 11 years	No
Primary	To create an electronic registry of data on the tolerant and comparison groups that will serve as the basis for statistical analyses		0 to 11 years	No
Primary	To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance		0 to 11 years	No
Primary	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		0 to 11 years	No

External Links

•   Immune Tolerance Network (ITN)
•   National Institute of Allergy and Infectious Diseases (NIAID)