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Completed

NCT Number: NCT01796639

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chaoyang Hospital, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Acronym: REACH

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 22, 2013
Registry last updated
Jun 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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