Study of Tolerant Kidney Transplant Recipients (FACTOR)

National Institute of Allergy and Infectious Diseases (NIAID)

Status: Completed

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

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01338779

DAIT ITN507ST

Details and patient eligibility

About

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.

Full 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).

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

197 participants in 11 patient groups

Group 1 - kidney tolerant

Description:

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

Description:

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

Description:

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

Description:

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

Description:

Enrollment for group 5 is closed. Stable renal transplant recipients currently on standard immunosuppression.

Group 6 - kidney chronic rejector

Description:

Enrollment for group 6 is closed. Chronic allograft nephropathy group.

Group 7 - kidney identical twin

Description:

Enrollment for group 7 is closed.

Group 8 - living kidney donors

Description:

Corresponding to recipients in group 1 or 4.

Group 9 - healthy controls

Description:

Enrollment for group 9 is closed.

Group 10 - liver tolerant

Description:

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

Description:

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.