The Histological Analysis in Renal Transplantation Patients With Deterioration of Graft Function

NCT ID: NCT01794871

Last Updated: 2013-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Allograft Dysfunction

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tongyu Zhu

Role: CONTACT

+8613816002121

Facility Contacts

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Ming Xu

Role: primary

+86-21-64037269

Other Identifiers

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COLO400ACN03T

Identifier Type: -

Identifier Source: org_study_id

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