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)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Estados Unidos, 02115
- Beth Israel Deaconess Medical Center
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New York
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New York, New York, Estados Unidos, 10029
- Mount Sinai School of Medicine
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- The Cleveland Clinic Foundation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Renal Transplant Recipients
Subjects who received a kidney transplant within the past 1 to 5 years
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The presence of at least one time point of the previously identified renal transplant tolerance signature.
Periodo de tiempo: 2 years
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
Periodo de tiempo: 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
Periodo de tiempo: 2 years
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2 years
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Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
Periodo de tiempo: 2 years
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2 years
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Selected clinical events and laboratory parameters to assess hematologic and renal function
Periodo de tiempo: 2 years
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2 years
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Colaboradores e Investigadores
Investigadores
- Silla de estudio: Kenneth Newell, MD, PhD, Emory University
- Silla de estudio: Laurence Turka, MD, Beth Israel Deaconess Medical Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- DAIT ITN524ST/CTOT-12
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