- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01516177
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)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Alabama
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Birmingham, Alabama, États-Unis, 35294
- University of Alabama Birmingham
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California
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San Francisco, California, États-Unis, 94143
- University of California San Francisco
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Emory University
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, États-Unis, 02115
- Beth Israel Deaconess Medical Center
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New York
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New York, New York, États-Unis, 10029
- Mount Sinai School of Medicine
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- The Cleveland Clinic Foundation
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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The presence of at least one time point of the previously identified renal transplant tolerance signature.
Délai: 2 years
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2 years
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Time course of potential changes in the previously identified renal transplant tolerance signature in individual participants.
Délai: 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
Délai: 2 years
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2 years
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Flow-cytometric measurements of cell populations distinguished by cell-surface phenotype
Délai: 2 years
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2 years
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Selected clinical events and laboratory parameters to assess hematologic and renal function
Délai: 2 years
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2 years
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Kenneth Newell, MD, PhD, Emory University
- Chaise d'étude: Laurence Turka, MD, Beth Israel Deaconess Medical Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- DAIT ITN524ST/CTOT-12
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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