Associating Renal Transplantation With the ITN Signature of Tolerance (ARTIST)

An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)

This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression. The study goal is to find out how common this pattern is in transplant patients, as a first step in determining if it can be used to personalize anti-rejection drug regimens better.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation

Detailed Description

Following surgery, kidney transplant patients must take medications in order to prevent rejection of their transplanted organ. These medications can be very effective. Called immunosuppressive drugs, they work by reducing the activity of the immune system. Because of this, however, they can also have serious side effects, including increased risks of serious infections and certain types of cancer.

The ITN Registry of Tolerant Kidney Transplant Recipients recently identified a rare group of people whose immune system has accepted their transplant without continued use of immunosuppressive drugs. Researchers have found that these patients have a unique pattern of cells and genes expressed in their blood compared to other transplant patients.

The ARTIST study will ask the questions "Are there other transplant patients who show this pattern?" and "If so, how often?"

The goal is to find out if there are other transplant patients who are taking immunosuppression who also show this pattern of genes. If there are others, then this pattern may one day be useful in identifying transplant patients who could reduce the dose of immunosuppression they need without fear of rejection.

Researchers are seeking adults who have received a kidney transplant within the past 1 to 5 years. Participants will be asked to attend 3 short appointments with study doctors over a period of 2 years. At these visits, doctors will request demographic and clinical information, relevant medical histories and blood and urine samples. Participants will be compensated for their time.

It is important to note that this is an observational study only. Other than receiving consultations and advice from the transplant team, there is no direct medical benefit to participating. However, by participating, patients may play an active part in helping doctors learn to control kidney transplant rejection more effectively, with fewer drugs.

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama Birmingham
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include 250 participants who are determined to be eligible for further follow-up based on the eligibility criteria.

Among those eligible for further follow-up

• at least 25 participants will be renal transplant recipients who received induction therapy with Campath, and
• at least 25 participants will be renal transplant recipients who are receiving sirolimus or everolimus at time of enrollment and who have not received calcineurin inhibitors for at least 30 days prior to enrollment

Description

Inclusion Criteria:

• Received first kidney transplant from a living or deceased donor.
• Kidney transplanted between 1 and 5 years ago.
• Calculated GFR of greater than or equal to 45 mL/min/1.73 m2 within last 6 months
• Ability to understand and provide informed consent.

Exclusion Criteria:

• History of steroid-resistant acute rejection
• History of two or more episodes of acute rejection
• Any acute rejection in the past year
• Current malignancy
• Transplant of another organ
• AIDS according to the CDC definition of AIDS.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Renal Transplant Recipients; Subjects who received a kidney transplant within the past 1 to 5 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The presence of at least one time point of the previously identified renal transplant tolerance signature.	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.	2 years
Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments	2 years
Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype	2 years
Selected clinical events and laboratory parameters to assess hematologic and renal function	2 years

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Immune Tolerance Network (ITN); Clinical Trials in Organ Transplantation
• Investigators: Study Chair: Kenneth Newell, MD, PhD, Emory University; Study Chair: Laurence Turka, MD, Beth Israel Deaconess Medical Center

Publications and helpful links

General Publications

• 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.

Helpful Links

• National Institute of Allergy and Infectious Diseases (NIAID) website
• Immune Tolerance Network website
• Clinical Trials in Organ Transplantation website

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: January 19, 2012
• First Submitted That Met QC Criteria: January 19, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: immunosuppression; Kidney Transplantation; kidney transplant; renal transplant
• Other Study ID Numbers: DAIT ITN524ST/CTOT-12