A Study on a New Staining Method (C4d Staining) of Transplanted Kidney Biopsies
| Tracking Information | |||||
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| First Received Date ICMJE | July 6, 2007 | ||||
| Last Updated Date | June 14, 2011 | ||||
| Start Date ICMJE | July 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00498095 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study on a New Staining Method (C4d Staining) of Transplanted Kidney Biopsies | ||||
| Official Title ICMJE | Experience of C4d Staining in Renal Allograft Biopsies | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Renal biopsy | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 52 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00498095 | ||||
| Other Study ID Numbers ICMJE | KW/EX/06-054, HARECCTR0500061 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Hospital Authority, Hong Kong | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Hospital Authority, Hong Kong | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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