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

This study is currently recruiting participants.
Verified February 2013 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01794871
First received: February 16, 2013
Last updated: February 20, 2013
Last verified: February 2013

February 16, 2013
February 20, 2013
May 2012
March 2013   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function [ Time Frame: January 2005 to December 2011 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01794871 on ClinicalTrials.gov Archive Site
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The Histological Analysis in Renal Transplantation Patients With Deterioration of Graft Function
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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.

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Observational
Time Perspective: Retrospective
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Retention:   Samples Without DNA
Description:

graft biopsy after kidney transplantation

Probability Sample

Maintenance living donor renal transplant recipients

Chronic Allograft Dysfunction
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Tongyu Zhu +8613816002121 tyzhu@fudan.edu.cn
China
 
NCT01794871
COLO400ACN03T
No
Shanghai Zhongshan Hospital
Shanghai Zhongshan Hospital
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Shanghai Zhongshan Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP