Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
REACH
1 other identifier
observational
1,500
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2013
CompletedFirst Posted
Study publicly available on registry
February 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJune 18, 2014
June 1, 2014
1.3 years
February 16, 2013
June 17, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Graft survival
Graft survival, measured as the time between kidney transplant and the failure of the graft.
5-year
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
Secondary Outcomes (7)
Average creatinine value
5 years
The rate of acute rejection episodes
5 years
The incidence of BPAR and its severity
5 years
The incidence of NODM
5 years
The incidence of infection
5 years
- +2 more secondary outcomes
Study Arms (1)
kidney transplantation patients with living-donor grafts
Eligibility Criteria
male and female kidney transplantation patients with living-donor grafts, \> 18 years of age
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (18)
The 309th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100000, China
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350025, China
The First affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Nanfang Hospital
Guangzhou, Guangdong, 510599, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Tongji Hospital
Wuhan, Hubei, 430030, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Shenyang Military General Hospital
Shenyang, Liaoning, China
Jinan Military General Hospital
Jinan, Shandong, 250000, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080, China
First Affiliated Hospital of Medical College of Xian Jiaotong University
Xian, Shanxi, 710061, China
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2013
First Posted
February 22, 2013
Study Start
April 1, 2012
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
June 18, 2014
Record last verified: 2014-06