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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01516177
Other study ID # DAIT ITN524ST/CTOT-12
Secondary ID
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


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
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