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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00498095
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : June 16, 2011
Information provided by:
Hospital Authority, Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment
Kidney Transplantation Graft Rejection Procedure: Renal biopsy

Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Experience of C4d Staining in Renal Allograft Biopsies
Study Start Date : July 2006
Actual Study Completion Date : December 2006

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00498095

Princess Margaret Hospital
Hong Kong, China
Sponsors and Collaborators
Hospital Authority, Hong Kong
Principal Investigator: Sze Kit Yuen, Dr Department of Medicine & Geriatrics, ICU, Caritas Medical Centre

Additional Information: Identifier: NCT00498095     History of Changes
Other Study ID Numbers: KW/EX/06-054
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by Hospital Authority, Hong Kong:
Delayed renal graft function
Acute renal allograft dysfunction