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)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Alabama
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Birmingham, Alabama, Spojené státy, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Spojené státy, 94143
- University of California San Francisco
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- Emory University
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Illinois
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Chicago, Illinois, Spojené státy, 60611
- Northwestern University
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Spojené státy, 02115
- Beth Israel Deaconess Medical Center
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New York
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New York, New York, Spojené státy, 10029
- Mount Sinai School of Medicine
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Ohio
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Cleveland, Ohio, Spojené státy, 44195
- The Cleveland Clinic Foundation
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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The presence of at least one time point of the previously identified renal transplant tolerance signature.
Časové okno: 2 years
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2 years
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
Časové okno: 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
Časové okno: 2 years
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2 years
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Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
Časové okno: 2 years
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2 years
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Selected clinical events and laboratory parameters to assess hematologic and renal function
Časové okno: 2 years
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2 years
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Kenneth Newell, MD, PhD, Emory University
- Studijní židle: Laurence Turka, MD, Beth Israel Deaconess Medical Center
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- DAIT ITN524ST/CTOT-12
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