Kidney TransplantationNCT00498095
A Study on a New Staining Method (C4d Staining) of Transplanted Kidney Biopsies
An observational study of Kidney Transplantation and Graft Rejection, run by Hospital Authority, Hong Kong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Graft Rejection
- What is being tested?
- Renal biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- Jul 2006to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- patients who were < 18 years' old at the time of renal biopsy or whose records were so incomplete that preclude meaningful analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Kidney Transplantation, Graft Rejection
- Being tested
- Renal biopsy
- Keywords
- Delayed renal graft function, Acute renal allograft dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal biopsyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2007 (estimated)
- Study startJul 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Investigators
- Sze Kit Yuen, Dr, Principal investigator, Department of Medicine & Geriatrics, ICU, Caritas Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00498095
- Sponsor's protocol ID
- KW/EX/06-054
- Other IDs
- HARECCTR0500061
- Status last verified
- Jun 2011
- First submitted
- 6 Jul 2007
- Last updated
- 16 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of C4d Staining in Renal Allograft Biopsies
- ClinicalTrials.gov ID
- NCT00498095
- Acronym / sponsor ID
- KW/EX/06-054
- Conditions
- Kidney Transplantation, Graft Rejection
- Keywords
- Delayed renal graft function, Acute renal allograft dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Jul 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- patients who were < 18 years' old at the time of renal biopsy or whose records were so incomplete that preclude meaningful analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal biopsy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sze Kit Yuen, Dr principal investigator
Department of Medicine & Geriatrics, ICU, Caritas Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Graft Rejection, run by Hospital Authority, Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.