Associating Renal Transplantation With the ITN Signature of Tolerance

Kidney Transplantation Clinical Trial

— ARTIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516177
• Other study ID #: DAIT ITN524ST/CTOT-12
• Status: Completed
• Phase: N/A
• First received: January 19, 2012
• Last updated: December 16, 2016
• Start date: September 2010
• Est. completion date: April 2014

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Kidney Transplantation

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mount Sinai School of Medicine	New York	New York
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Clinical Trials in Organ Transplantation, Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence of at least one time point of the previously identified renal transplant tolerance signature.		2 years	No
Secondary	Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.		2 years	No
Secondary	Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments		2 years	No
Secondary	Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype		2 years	No
Secondary	Selected clinical events and laboratory parameters to assess hematologic and renal function		2 years	No

External Links

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