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

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 Overview

• Status: Unknown
• Conditions: Chronic Allograft Dysfunction

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Tongyu Zhu; Phone Number: +8613816002121; Email: tyzhu@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Ming Xu; Phone Number: +86-21-64037269

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Maintenance living donor renal transplant recipients

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function	up to 6 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): August 1, 2013

Study Registration Dates

• First Submitted: February 16, 2013
• First Submitted That Met QC Criteria: February 16, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: COLO400ACN03T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No