- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Wiwat Chancharoenthana, MD, Msc
- E-post: wiwatmd@hotmail.com
Studiesteder
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Bangkok, Thailand, 10330
- Rekruttering
- Wiwat Chancharoenthana
-
Ta kontakt med:
- Wiwat Chancharoenthana, MD, Msc
- E-post: wiwatmd@hotmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
HBsAg negative kidney allograft donor
|
|
HBsAg positive kidney allograft donor
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Hepatitis B transmission rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Graft survival rate
Tidsramme: January 2000 to December 2013
|
The graft survival rate was determined by Kaplan-Meyer survival analysis.
|
January 2000 to December 2013
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Patient survival rate
Tidsramme: January 2000 to December 2013
|
The patient survival rate was determined by Kaplan-Meyer survival analysis.
|
January 2000 to December 2013
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Wiwat Chancharoenthana, MD, MSc, Chulalongkorn University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WWC-001
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Kliniske studier på HBsAg positive kidney allograft donor
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Maidstone & Tunbridge Wells NHS TrustRekruttering
-
Womb Transplant UKImperial College LondonUkjent