A Study on a New Staining Method (C4d Staining) of Transplanted Kidney Biopsies

This study has been completed.
Sponsor:
Information provided by:
Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT00498095
First received: July 6, 2007
Last updated: June 14, 2011
Last verified: June 2011

July 6, 2007
June 14, 2011
July 2006
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Complete list of historical versions of study NCT00498095 on ClinicalTrials.gov Archive Site
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A Study on a New Staining Method (C4d Staining) of Transplanted Kidney Biopsies
Experience of C4d Staining in Renal Allograft Biopsies

Patients who had received kidney transplantation may suffer from rejection. Recently, positive staining for C4d in kidney biopsies of malfunctioning transplant kidney is increasingly recognized as an important prognostic indicator of poorer long-term kidney outcome. Data is, however, lacking in Hong Kong.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

All renal allograft biopsies performed in Princess Margaret Hospital from 1st April 2002 to 31st March 2006 on Chinese patients who were ≥ 18 years old were retrospectively reviewed. Renal transplantations were either cadaveric or living-donor related performed in Hong Kong or Mainland China. All recipients' sera produced negative cross-match tests with donor lymphocytes before transplantation and were ABO compatible. Finally, 52 renal biopsies were included. 38 (73.1%) of them were performed for unexplained acute renal deterioration whilst the rest were done for delayed graft function.

  • Kidney Transplantation
  • Graft Rejection
Procedure: Renal biopsy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
December 2006
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Inclusion Criteria:

  • All renal allograft biopsies performed in Princess Margaret Hospital (PMH) during the period 1st April 2003 to 31st August 2005 for unexplained acute renal dysfunction (Creatinine rise from baseline by ≥ 20%) or delayed graft function in the immediate post-transplantation period were included in the study. Both cadaveric and living-donor transplant allografts were included.

Exclusion Criteria:

  • patients who were < 18 years' old at the time of renal biopsy or whose records were so incomplete that preclude meaningful analysis
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
China
 
NCT00498095
KW/EX/06-054, HARECCTR0500061
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Hospital Authority, Hong Kong
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Principal Investigator: Sze Kit Yuen, Dr Department of Medicine & Geriatrics, ICU, Caritas Medical Centre
Hospital Authority, Hong Kong
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP