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

June 14, 2011 updated by: Hospital Authority, Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: Sze Kit Yuen, Dr, Department of Medicine & Geriatrics, ICU, Caritas Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

July 6, 2007

First Submitted That Met QC Criteria

July 6, 2007

First Posted (Estimate)

July 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 16, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KW/EX/06-054
  • HARECCTR0500061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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