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)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Alabama
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Birmingham, Alabama, Stati Uniti, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Stati Uniti, 94143
- University of California San Francisco
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Georgia
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Atlanta, Georgia, Stati Uniti, 30322
- Emory University
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Northwestern University
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Stati Uniti, 02115
- Beth Israel Deaconess Medical Center
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New York
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New York, New York, Stati Uniti, 10029
- Mount Sinai School of Medicine
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Ohio
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Cleveland, Ohio, Stati Uniti, 44195
- The Cleveland Clinic Foundation
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The presence of at least one time point of the previously identified renal transplant tolerance signature.
Lasso di tempo: 2 years
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2 years
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
Lasso di tempo: 2 years
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2 years
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Expression levels for a wide variety of genes measured by large-scale microarray or by PCR assessments
Lasso di tempo: 2 years
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2 years
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Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
Lasso di tempo: 2 years
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2 years
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Selected clinical events and laboratory parameters to assess hematologic and renal function
Lasso di tempo: 2 years
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2 years
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Collaboratori e investigatori
Investigatori
- Cattedra di studio: Kenneth Newell, MD, PhD, Emory University
- Cattedra di studio: Laurence Turka, MD, Beth Israel Deaconess Medical Center
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- DAIT ITN524ST/CTOT-12
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