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

This study has been completed.
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Clinical Trials in Organ Transplantation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01516177
First received: January 19, 2012
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition
Kidney Transplantation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • The presence of at least one time point of the previously identified renal transplant tolerance signature. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Selected clinical events and laboratory parameters to assess hematologic and renal function [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood Isolation PBMC isolated RNA specimens


Enrollment: 250
Study Start Date: September 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Renal Transplant Recipients
People who have received a kidney transplant within the past 1 to 5 years

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516177

Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Immune Tolerance Network (ITN)
Clinical Trials in Organ Transplantation
Investigators
Study Chair: Anil Chandraker, MD Brigham and Women's Hospital
Study Chair: Kenneth Newell, MD, PhD Emory University
Study Chair: Laurence Turka, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01516177     History of Changes
Other Study ID Numbers: DAIT ITN524ST/CTOT-12
Study First Received: January 19, 2012
Last Updated: May 29, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney Transplantation
kidney transplant
renal transplant
immunosuppression

ClinicalTrials.gov processed this record on August 28, 2014