NCT01796639

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

18 active sites

Status
completed

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

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 18, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

February 16, 2013

Last Update Submit

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Study Sites (18)

The 309th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100000, China

Location

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Fuzhou General Hospital of Nanjing Military Command

Fuzhou, Fujian, 350025, China

Location

The First affiliated Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Nanfang Hospital

Guangzhou, Guangdong, 510599, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

Location

Shenyang Military General Hospital

Shenyang, Liaoning, China

Location

Jinan Military General Hospital

Jinan, Shandong, 250000, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

First Affiliated Hospital of Medical College of Xian Jiaotong University

Xian, Shanxi, 710061, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

Location

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

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

Locations