Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China

Kidney Transplantation Clinical Trial

— REACH  

Official title:

Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01796639
• Other study ID #: COLO400ACN02
• Status: Completed
• Phase: N/A
• First received: February 16, 2013
• Last updated: June 17, 2014
• Start date: April 2012
• Est. completion date: August 2013

Study information

• Verified date: June 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The primary objective of this study is to evaluate graft survival and recipient survival among kidney transplant recipients in China, and also to analyze possible factors related to patient and graft survival.

The secondary objective is to evaluate several secondary outcomes among kidney transplant recipients, such as average creatinine value, acute rejection episodes, NODM, incidence of BKV infection etc. At the same time analyze possible impact factors related to these secondary outcomes.

Description:

Renal transplantation is the choice for patients with end-stage renal disease. In the past two decades, progress in surgical procedure, medical care, and immunosuppression have significantly improved the short-term results of organ transplantation. Nevertheless, grafts continue to fail over time, these improvements in immunosuppression and reduced incidence of acute rejection episodes have had only minimal effects on chronic allograft dysfunction and late graft loss. Long-term patient's death and graft failure are the main limitations for a better performance of renal transplant programs.

Multiple factors have been shown to affect the outcome of renal transplantation. These include demographic characteristics such as race and ethnicity, pretransplantation dialysis course, the timing of the transplantation，and the patients' co morbidities. Patient response to the transplantation procedure (e.g., delayed graft function, acute rejection, and acute tubular necrosis) is strongly associated with the long-term prognosis. In the last decade, with the increase of immunosuppressive agents in our therapeutic arsenal, several attempts have been made to improve graft performance. However, the majority of trials aiming to avoid calcineurin inhibitor (CNI)-related nephrotoxicity only reported short-term data. Also, and because of the lack of assessment of the role of the different ethiopathogenic factors that lead to graft damage, just avoiding CNI-related nephrotoxicity may be an oversimplification of the problem in the prevention of graft attrition.

There are many studies which have evaluated the long-term outcomes of graft and patient survival and have analyzed multiple relative factors. Unfortunately, such data in Chinese population are lacking. Meanwhile, the situation in China is somewhat different with others, such as race, the dosage of immunosuppressant and so on. A better characterization of the weight of immune and non-immune factors responsible for graft damage may help us to improve the outcomes in transplant recipients. Studies derived from well-designed and well-performed patient registries can provide a real world view of clinical practice, patient outcomes, safety, and comparative effectiveness and cost effectiveness. The goal of this project is to analyze retrospective data collected by disease registry, then to evaluate the graft and recipient outcomes of kidney transplants and relative impact factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Kidney transplant recipients

• Received a transplant from Jan 1,1995 to Dec 31, 2007, only including those with living donor grafts

• Age: 18-75 years

Exclusion Criteria:

• Multiple-organ transplant recipients

• Patients records with missing information in 12 months post-transplantation

• Patients who did not have the information regarding their maintenance immunosuppressive therapy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Transplantation

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The 309th Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital,Sichuan University	Chengdu	Sichuan
China	Fuzhou General Hospital of Nanjing Military Command	Fuzhou	Fujian
China	Nanfang Hospital	Guangzhou	Guangdong
China	The First affiliated Hospital Sun Yat-sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Jinan Military General Hospital	Jinan	Shandong
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Shenyang Military General Hospital	Shenyang	Liaoning
China	Tongji Hospital	Wuhan	Hubei
China	First Affiliated Hospital of Medical College of Xian Jiaotong University	Xian	Shanxi
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft survival	Graft survival, measured as the time between kidney transplant and the failure of the graft.	5-year	No
Primary	Recipient survival	measured as the time between the most recent kidney transplant and the patient's death. Graft outcome was censored at the earliest of the following events and was analyzed as days to graft failure or censor: loss to follow-up, patient death.	5-year	No
Secondary	Average creatinine value		5 years	Yes
Secondary	The rate of acute rejection episodes		5 years	No
Secondary	The incidence of BPAR and its severity		5 years	No
Secondary	The incidence of NODM		5 years	Yes
Secondary	The incidence of infection		5 years	Yes
Secondary	The incidence of biopsy proven CNIs nephrotoxicity		5 years	Yes
Secondary	The rate of posttransplantation malignancies		5 years	Yes