- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02044588
Hepatitis B Antigen Kidney Graft Into Protective Level Hepatitis B Antibody Recipients
The Outcomes of Kidney Transplantation Between Recipients Receiving Graft From Donors With Positive and Negative HBsAg
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The kidney transplant registry was conducted in KCMH since the year of 2000 until the present.
The inclusion criterion was:
- All kidney allograft recipients who received at least one month after transplantation.
- All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.
The exclusion criterion was:
- The recipients with positive hepatitis C virus antibody.
- The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
- The recipients those lost to follow-up.
Study group:
- The recipients who received kidney allograft from the HBsAg(+) donor.
Control group:
- The recipients who received kidney allograft from the HBsAg(-) donor.
According to the Thai Red Cross National Organ Donation and our institute's policy, the HBsAg(+) kidney allografts were distributed to only and informed consent.
Data collection:
- Baseline characteristic data e.g. donor and recipient age, donor and recipient gender, HLA, PRA, anti-HBs titer, immunity against HBV status (both natural and vaccinated),immunosuppressive regimens were collected.
- The recipients were prospective followed up at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120.
- Clinical data including jaundice, hepatitis, graft rejection were collected
- Laboratory data of HBsAg, anti-HBc, HBV DNA, SGOT, SGOT, eGFR were collected.
- Pathological data of allograft biopsy at month 12 and 24 were retrieved.
Outcomes:
- Primary outcome: hepatitis B transmission rate.
- Secondary outcome: graft survival, patient survival.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Bangkok, Thaïlande, 10330
- Recrutement
- Wiwat Chancharoenthana
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Contact:
- Wiwat Chancharoenthana, MD, Msc
- E-mail: wiwatmd@hotmail.com
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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
The inclusion criterion was:
- All kidney allograft recipients who received at least one month after transplantation.
- All kidney recipients who already had the protective antibody against hepatitis B virus infection defined by anti-HBs titer above 100 mIU/mL at pre-transplantation period.
The exclusion criterion was:
- The recipients with positive hepatitis C virus antibody.
- The recipients who had received a previous or simultaneous non-kidney solid organ transplant.
- The recipients those lost to follow-up.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
HBsAg negative kidney allograft donor
|
|
HBsAg positive kidney allograft donor
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Hepatitis B transmission rate
Délai: January 2000 to December 2013
|
The hepatitis B transmission rate was determined at month 3, 6, 9, 12, 18, 24, 36, 48, 60, 72, 84, 96, 108, 120 by using:
|
January 2000 to December 2013
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Graft survival rate
Délai: January 2000 to December 2013
|
The graft survival rate was determined by Kaplan-Meyer survival analysis.
|
January 2000 to December 2013
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patient survival rate
Délai: January 2000 to December 2013
|
The patient survival rate was determined by Kaplan-Meyer survival analysis.
|
January 2000 to December 2013
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Wiwat Chancharoenthana, MD, MSc, Chulalongkorn University
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
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
- WWC-001
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