Chronic Allograft DysfunctionNCT01794871
The Histological Analysis in Renal Transplantation Patients With Deterioration of Graft Function
An observational study of Chronic Allograft Dysfunction, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplant recipients, then to identify the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual impact of both immunologic and nonimmunologic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Allograft Dysfunction
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Aug 2013
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Maintenance living donor renal transplant recipients
Who may be able to join
- 18 years of age or older
- Kidney transplant recipients, only including recipients of living-donor grafts
- Underwent an allograft biopsy between January 2005 and December 2011 because of developing deterioration of graft function*.
- Deterioration of function was defined as (1) an unexplained and persistent greater than or equal to 25% increase of CR over baseline (in the absence of potential confounding factors) or (2) new onset proteinuria (defined as albumin/CR ratio ≥0.2 or a protein/CR ratio >0.5).
Who cannot join
- Multiple organ transplants, prior transplant with any other organ or tissue
- Patients who did not have the information regarding the pathological diagnosis
- Patients who did not have the histological sections of the allograft biopsy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Ming Xu, +86-21-64037269
About this study
Identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplant recipients, then to identify the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor [CNI]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered one of the major causes of CAD, however, recently there has been found most death-censored graft losses to be the result of alloimmune or autoimmune injury, with only a minority of cases attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in CAD in China is not well analyzed. To improve perception of Neo safety with more local evidence, we want to do a retrospective study to identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplantation recipients.
- Conditions
- Chronic Allograft Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function
Measured: up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startMay 2012
- Primary completionMar 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Allograft DysfunctionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794871
- Sponsor's protocol ID
- COLO400ACN03T
- Status last verified
- Feb 2013
- First submitted
- 16 Feb 2013
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Histological Analysis in Renal Transplantation Patients With Deterioration of Graft Function
- ClinicalTrials.gov ID
- NCT01794871
- Acronym / sponsor ID
- COLO400ACN03T
- Conditions
- Chronic Allograft Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 20 Feb 2013 (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.
Identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplant recipients, then to identify the position of CNI nephrotoxicity in CAD.Chronic allograft dysfunction reflects the dual impact of both immunologic and nonimmunologic (primarily calcineurin inhibitor [CNI]nephrotoxicity) injury. In previous, CNI nephrotoxicity is overstated and considered one of the major causes of CAD, however, recently there has been found most death-censored graft losses to be the result of alloimmune or autoimmune injury, with only a minority of cases attributable to CNI toxicity. Unfortunately, Situation of objective CNI toxicity in CAD in China is not well analyzed. To improve perception of Neo safety with more local evidence, we want to do a retrospective study to identify the cause of chronic allograft dysfunction using a combination of comprehensive clinical and histologic information in Chinese renal transplantation recipients.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Maintenance living donor renal transplant recipients
Key inclusion criteria (4 listed)
- 18 years of age or older
- Kidney transplant recipients, only including recipients of living-donor grafts
- Underwent an allograft biopsy between January 2005 and December 2011 because of developing deterioration of graft function*.
Key exclusion criteria (3 listed)
- Multiple organ transplants, prior transplant with any other organ or tissue
- Patients who did not have the information regarding the pathological diagnosis
- Patients who did not have the histological sections of the allograft biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function
Time frame: up to 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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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.
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 Chronic Allograft Dysfunction, run by Shanghai Zhongshan Hospital 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Feb 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tongyu Zhu (+8613816002121, tyzhu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function (time frame: up to 6 years). It is what the study was designed to measure, not a finding.
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 22 Feb 2013.