- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
-
-
-
Bangkok, Thailand, 10330
- Rekrutierung
- Wiwat Chancharoenthana
-
Kontakt:
- Wiwat Chancharoenthana, MD, Msc
- E-Mail: wiwatmd@hotmail.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
HBsAg negative kidney allograft donor
|
|
|
HBsAg positive kidney allograft donor
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Hepatitis B transmission rate
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Graft survival rate
Zeitfenster: January 2000 to December 2013
|
The graft survival rate was determined by Kaplan-Meyer survival analysis.
|
January 2000 to December 2013
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Patient survival rate
Zeitfenster: January 2000 to December 2013
|
The patient survival rate was determined by Kaplan-Meyer survival analysis.
|
January 2000 to December 2013
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Wiwat Chancharoenthana, MD, MSc, Chulalongkorn University
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- WWC-001
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