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

• Conditions: Chronic Allograft Dysfunction

• Registration Number: NCT01794871
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-05
• Status Verified: 2013-02
• Study First Submitted: 2013-02-16
• Study First Submitted QC: 2013-02-16
• Study First Posted: 2013-02-20
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-22
• Primary Completion: 2013-03
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function	up to 6 years

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China