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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01796639
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China
Study Start Date : April 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Group/Cohort
kidney transplantation patients with living-donor grafts



Primary Outcome Measures :
  1. Graft survival [ Time Frame: 5-year ]
    Graft survival, measured as the time between kidney transplant and the failure of the graft.

  2. 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.


Secondary Outcome Measures :
  1. Average creatinine value [ Time Frame: 5 years ]
  2. The rate of acute rejection episodes [ Time Frame: 5 years ]
  3. The incidence of BPAR and its severity [ Time Frame: 5 years ]
  4. The incidence of NODM [ Time Frame: 5 years ]
  5. The incidence of infection [ Time Frame: 5 years ]
  6. The incidence of biopsy proven CNIs nephrotoxicity [ Time Frame: 5 years ]
  7. The rate of posttransplantation malignancies [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
male and female kidney transplantation patients with living-donor grafts, > 18 years of age
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796639


Locations
Show Show 18 study locations
Sponsors and Collaborators
Novartis
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01796639    
Other Study ID Numbers: COLO400ACN02
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014