Study of Tolerant Kidney Transplant Recipients

Completed

• Conditions: Renal Transplantation; Transplant Rejection; Renal Transplant; Transplant Tolerance; Kidney Transplantation

• Registration Number: NCT01338779
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-20
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
To identify individuals who have received a kidney transplant and who have achieved a state of immune tolerance to graft	0 to 11 years
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
To use data from the registry to perform classical tests of hypotheses regarding the establishment of immune tolerance	0 to 11 years

Trial Locations

Locations (4)

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