Kidney TransplantationARTISTNCT01516177
Associating Renal Transplantation With the ITN Signature of Tolerance
An observational study of Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation
- How many people
- 250 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2010to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory University
Atlanta, Georgia, 30322
University of Alabama Birmingham
Birmingham, Alabama, 35294
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Mount Sinai School of Medicine
New York, New York, 10029
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, kidney transplant, renal transplant, immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Renal Transplant Recipients | Subjects who received a kidney transplant within the past 1 to 5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
The presence of at least one time point of the previously identified renal transplant tolerance signature.
Measured: 2 years
Secondary outcomes (4)
Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
Measured: 2 years
Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments
Measured: 2 years
Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
Measured: 2 years
Selected clinical events and laboratory parameters to assess hematologic and renal function
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startSep 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), Clinical Trials in Organ Transplantation
- Responsible party
- Sponsor
- Investigators
- Anil Chandraker, MD, Study chair, Brigham and Women's HospitalKenneth Newell, MD, PhD, Study chair, Emory UniversityLaurence Turka, MD, Study chair, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516177
- Sponsor's protocol ID
- DAIT ITN524ST/CTOT-12
- Acronym
- ARTIST
- Status last verified
- Sep 2026
- First submitted
- 19 Jan 2012
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20501946
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients (ITN524ST/CTOT-12)
- ClinicalTrials.gov ID
- NCT01516177
- Acronym / sponsor ID
- ARTIST / DAIT ITN524ST/CTOT-12
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplantation, kidney transplant, renal transplant, immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Immune Tolerance Network (ITN), Clinical Trials in Organ Transplantation
- Study start
- Sep 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Transplant Recipients | – | –Subjects who received a kidney transplant within the past 1 to 5 years |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The presence of at least one time point of the previously identified renal transplant tolerance signature.
Time frame: 2 years
4 secondary outcomes
Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
Time frame: 2 years
Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments
Time frame: 2 years
Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
Time frame: 2 years
Selected clinical events and laboratory parameters to assess hematologic and renal function
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 20501946Newell 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.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
- Immune Tolerance Network websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Chandraker, MD study chair
Brigham and Women's Hospital
Kenneth Newell, MD, PhD study chair
Emory University
Laurence Turka, MD study chair
Beth Israel Deaconess Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of at least one time point of the previously identified renal transplant tolerance signature. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.