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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
History of Changes
  Purpose

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.


Condition
Chronic Allograft Dysfunction

Study Type: Observational
Study Design: Time Perspective: Retrospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

graft biopsy after kidney transplantation


Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Maintenance living donor renal transplant recipients

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794871

Contacts
Contact: Tongyu Zhu +8613816002121 tyzhu@fudan.edu.cn

Locations
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ming Xu     +86-21-64037269        
Sponsors and Collaborators
Shanghai Zhongshan Hospital
  More Information

No publications provided

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01794871     History of Changes
Other Study ID Numbers: COLO400ACN03T
Study First Received: February 16, 2013
Last Updated: February 20, 2013
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on May 16, 2013