Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
- Conditions
- Kidney Transplantation
- Registration Number
- NCT01796639
- Lead Sponsor
- Novartis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft survival 5-year Graft survival, measured as the time between kidney transplant and the failure of the graft.
Recipient survival 5-year 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.
- Secondary Outcome Measures
Name Time Method Average creatinine value 5 years The incidence of biopsy proven CNIs nephrotoxicity 5 years The rate of posttransplantation malignancies 5 years The incidence of NODM 5 years The incidence of infection 5 years The rate of acute rejection episodes 5 years The incidence of BPAR and its severity 5 years
Trial Locations
- Locations (18)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
West China Hospital,Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
The First affiliated Hospital Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Fuzhou General Hospital of Nanjing Military Command
🇨🇳Fuzhou, Fujian, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
The 309th Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
Beijing Chaoyang Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
Shenyang Military General Hospital
🇨🇳Shenyang, Liaoning, China
Jinan Military General Hospital
🇨🇳Jinan, Shandong, China
Shanghai First People's Hospital
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of Medical College of Xian Jiaotong University
🇨🇳Xian, Shanxi, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China