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

Chronic Allograft Dysfunction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01794871
• Other study ID #: COLO400ACN03T
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2013
• Last updated: February 20, 2013
• Start date: May 2012
• Est. completion date: August 2013

Study information

• Verified date: February 2013
• Source: Shanghai Zhongshan Hospital
• Contact: Tongyu Zhu
• Phone: +8613816002121
• Email: tyzhu[@]fudan.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Chronic Allograft Dysfunction

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the graft biopsy of maintenance living donor renal transplant recipients who underwent deterioration of graft function		up to 6 years	Yes