Clinical trial NCT01796639: Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
Official title: Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-02-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male and female kidney transplantation patients with living-donor grafts, \> 18 years of age

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft survival
timeFrame: 5-year
measure: Recipient survival
timeFrame: 5-year
Secondary outcomes:
measure: Average creatinine value
timeFrame: 5 years
measure: The rate of acute rejection episodes
timeFrame: 5 years
measure: The incidence of BPAR and its severity
timeFrame: 5 years
measure: The incidence of NODM
timeFrame: 5 years
measure: The incidence of infection
timeFrame: 5 years
measure: The incidence of biopsy proven CNIs nephrotoxicity
timeFrame: 5 years
measure: The rate of posttransplantation malignancies
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 309th Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fuzhou General Hospital of Nanjing Military Command
state: Fujian
city: Guangzhou
country: China
facility: The First affiliated Hospital Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: Shenyang Military General Hospital
state: Liaoning
city: Jinan
country: China
facility: Jinan Military General Hospital
state: Shandong
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Xian
country: China
facility: First Affiliated Hospital of Medical College of Xian Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
Study officials:
References: