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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Kidney Transplantation

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Trial Information

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


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´╝îand 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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Graft survival

Outcome Description:

Graft survival, measured as the time between kidney transplant and the failure of the graft.

Outcome Time Frame:

5-year

Safety Issue:

No

Authority:

China: Ethics Committee

Study ID:

COLO400ACN02

NCT ID:

NCT01796639

Start Date:

April 2012

Completion Date:

July 2013

Related Keywords:

  • Kidney Transplantation

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