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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation

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.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100000
      • The 309th Hospital of Chinese People's Liberation Army
    • Beijing, Beijing, China, 100020
      • Beijing ChaoYang Hospital
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350025
      • Fuzhou General hospital of Nanjing Military Command
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510599
      • Nanfang Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital
  • Hunan
    • Changsha, Hunan, China, 410000
      • The Second Xiangya Hospital of Central South University
  • Liaoning
    • Shenyang, Liaoning, China
      • Shenyang Military General Hospital
  • Shandong
    • Jinan, Shandong, China, 250000
      • Jinan Military General Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Fudan University
    • Shanghai, Shanghai, China, 200080
      • Shanghai First People's Hospital
  • Shanxi
    • Xian, Shanxi, China, 710061
      • First Affiliated Hospital Of Medical College of Xian Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital,Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

male and female kidney transplantation patients with living-donor grafts, > 18 years of age

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
kidney transplantation patients with living-donor grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
The incidence of biopsy proven CNIs nephrotoxicity	5 years
The rate of posttransplantation malignancies	5 years

Collaborators and Investigators

• Sponsor: Novartis

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: February 16, 2013
• First Submitted That Met QC Criteria: February 20, 2013
• First Posted (Estimate): February 22, 2013

Study Record Updates

• Last Update Posted (Estimate): June 18, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: COLO400ACN02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No