Kidney TransplantationREACHNCT01796639
Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
An observational study of Kidney Transplantation, run by Novartis at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- How many people
- 1,500 participants
- Where
- 18 sitesChina
- Study dates
- Apr 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male and female kidney transplantation patients with living-donor grafts, > 18 years of age
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
The 309th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100000
Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, 350025
The First affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 510080
Nanfang Hospital
Guangzhou, Guangdong, 510599
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
Jinan Military General Hospital
Jinan, Shandong, 250000
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
Shenyang Military General Hospital
Shenyang, Liaoning
Tongji Hospital
Wuhan, Hubei, 430030
First Affiliated Hospital of Medical College of Xian Jiaotong University
Xian, Shanxi, 710061
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
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.
Read the 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.
- Conditions
- Kidney Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| kidney transplantation patients with living-donor grafts | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft survival
Graft survival, measured as the time between kidney transplant and the failure of the graft.
Measured: 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.
Measured: 5-year
Secondary outcomes (7)
Average creatinine value
Measured: 5 years
The rate of acute rejection episodes
Measured: 5 years
The incidence of BPAR and its severity
Measured: 5 years
The incidence of NODM
Measured: 5 years
The incidence of infection
Measured: 5 years
The incidence of biopsy proven CNIs nephrotoxicity
Measured: 5 years
The rate of posttransplantation malignancies
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startApr 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796639
- Sponsor's protocol ID
- COLO400ACN02
- Acronym
- REACH
- Status last verified
- Jun 2014
- First submitted
- 16 Feb 2013
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
- ClinicalTrials.gov ID
- NCT01796639
- Acronym / sponsor ID
- REACH / COLO400ACN02
- Conditions
- Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 22 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| kidney transplantation patients with living-donor grafts | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female kidney transplantation patients with living-donor grafts, > 18 years of age
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft survival
Time frame: 5-year
Graft survival, measured as the time between kidney transplant and the failure of the graft.
Recipient survival
Time frame: 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.
7 secondary outcomes
Average creatinine value
Time frame: 5 years
The rate of acute rejection episodes
Time frame: 5 years
The incidence of BPAR and its severity
Time frame: 5 years
The incidence of NODM
Time frame: 5 years
The incidence of infection
Time frame: 5 years
The incidence of biopsy proven CNIs nephrotoxicity
Time frame: 5 years
The rate of posttransplantation malignancies
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation, run by Novartis at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft survival (time frame: 5-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.