- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02335333
Biomarkers of Aging as Predictors of Kidney Transplant Function
Clinical Utility of Biomarkers of Aging as Predictors of Kidney Graft Function in Extended Criteria Organ Recipients
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Presently, donated organs are ranked amongst each other based on a formula for Kidney Donor Patient Index (KDPI; a variation of Donor Risk index) 8 which includes donor demographics and clinical history but no molecular markers of kidney function other than serum creatinine. Using KDPI assessment, nearly all ECD kidneys fall into the high-risk category. And while ECD kidneys are associated with higher risk of graft failure, studies note a wide variability in ECD organ quality and the associated graft survival (half-life graft survival 4.5-7.9 years), suggesting that current models of assessing organ quality are inadequate. Furthermore, prior to even being assigned a KDPI, over 37% of all kidneys and over 50% of ECD kidneys are discarded based on biopsy findings. However, recent studies called into question the reliance on procurement kidney biopsy reports in making acceptance decisions by demonstrating significant overlap in the biopsy findings between discarded and transplanted kidneys. The use of ECD kidneys is becoming more widespread and, according to a recent report, 70% adults >65yo and 50% adults between 50 and 64 yo are willing to accept an ECD kidney. Therefore, new methodology for assessment of graft viability would increase transplantation rates particularly for organs from older or expanded criteria donors, shorten patient's time on wait list (currently 45 months average 50) and improve their outcomes by taking them off dialysis sooner.
Here, we propose a new approach-using molecular age markers (collectively referred to as SenesceTest) to predict kidney graft function.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- Unc Hospitals
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Winston-Salem, North Carolina, États-Unis
- Wake Forest Baptist Health, Abdominal Organ Transplant Program
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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
La description
Inclusion Criteria:
- Donor > 35 years of age
Exclusion Criteria:
- Recipient is HIV positive
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Slow graft function (SGF; decline in serum creatinine >20% within 24h after transplant, no dialysis)
Délai: 24h
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24h
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Delayed graft function (DGF; need for dialysis during first week after transplant)
Délai: 1 week
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1 week
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Long-term graft function measured by change in serum creatinine (delta1-12eGFR)
Délai: 12 months
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12 months
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Long-term graft function measured by change in serum creatinine (delta1-6eGFR)
Délai: 6 months
|
6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: David Gerber, MD, University of North Carolina- Department of Surgery
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HSDX-1501
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