- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01879124
Resistive Index Measurements After Kidney Transplantation
Correlation Between Renal Vascular Resistive Index, Renal Allograft Histology and Outcome
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Since March 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the University Hospitals Leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. The biopsies are scheduled using a dedicated Microsoft Access database ("Biopsy Database"), that is maintained on the central servers of the University Hospitals Leuven. Patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. These biopsies are also recorded in the aforementioned Microsoft Access Database.
All clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (CCL database until 06/2012, transferred to the central KWS database in 2012). This electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. No written records are collected.
All renal allograft biopsies will be rescored by a single renal pathologist according to the most recent Banff classification, blinded for the clinical parameters and timing of the biopsy. These rescoring data are directly entered in the dedicated Microsoft Access database ("Biopsy Database").
Just prior to performing a renal allograft biopsy with ultrasound guidance, and as part of the routine clinical procedure, duplex measurements are performed by the radiologist who will perform the biopsy. The peak systolic velocity (Vmax) and the minimal diastolic velocity (Vmin) are determined in each patient in two to three representative interlobar arteries. The resistive index is calculated as [1 - (V min/V max)]. This procedure is repeated at three different places in the kidney (lower, interpolar and upper pole). These data are directly entered in the central electronic clinical database system (KWS, see above).
All electronic data will be transferred to a SAS database at time of data extraction.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Leuven, Belgique, 3000
- Universitaire Ziekenhuizen Leuven
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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:
Single kidney transplantation
Exclusion Criteria:
None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Kidney transplant recipients
All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Overall renal allograft survival
Délai: 7 years after transplantation
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7 years after transplantation
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Death-censored graft survival
Délai: 7 years after transplantation
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7 years after transplantation
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Patient survival
Délai: 7 years after transplantation
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7 years after transplantation
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Reduction of 50% or more in the eGFR from the value measured at the time of ultrasonography
Délai: 7 years after transplantation
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7 years after transplantation
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Maarten Naesens, MD PhD, Universitaire Ziekenhuizen KU Leuven
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KidneyTX-UZLEUVEN-RI
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