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NCT00498095 Clinical Trial

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

Kidney Transplantation Clinical Trial

Official title:
Experience of C4d Staining in Renal Allograft Biopsies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00498095
Other study ID # KW/EX/06-054
Secondary ID HARECCTR0500061
Status Completed
Phase N/A
First received July 6, 2007
Last updated June 14, 2011
Start date July 2006
Est. completion date December 2006

Study information
Verified date June 2011
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Renal biopsy

Locations
Country Name City State
China Princess Margaret Hospital Hong Kong

Sponsors (1)
Lead Sponsor Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

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