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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794871
First Posted: February 20, 2013
Last Update Posted: February 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
  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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01794871     History of Changes
Other Study ID Numbers: COLO400ACN03T
First Submitted: February 16, 2013
First Posted: February 20, 2013
Last Update Posted: February 22, 2013
Last Verified: February 2013


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