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

17. juni 2014 opdateret af: Novartis

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Beijing
      • Beijing, Beijing, Kina, 100034
        • Peking University First Hospital
      • Beijing, Beijing, Kina, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, Kina, 100000
        • The 309th Hospital of Chinese People's Liberation Army
      • Beijing, Beijing, Kina, 100020
        • Beijing ChaoYang Hospital
      • Beijing, Beijing, Kina, 100050
        • Beijing Friendship Hospital
    • Fujian
      • Fuzhou, Fujian, Kina, 350025
        • Fuzhou General hospital of Nanjing Military Command
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • The First Affiliated Hospital Sun Yat-Sen University
      • Guangzhou, Guangdong, Kina, 510599
        • Nanfang Hospital
    • Henan
      • Zhengzhou, Henan, Kina, 450052
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Tongji Hospital
    • Hunan
      • Changsha, Hunan, Kina, 410000
        • The Second Xiangya Hospital of Central South University
    • Liaoning
      • Shenyang, Liaoning, Kina
        • Shenyang Military General Hospital
    • Shandong
      • Jinan, Shandong, Kina, 250000
        • Jinan Military General Hospital
    • Shanghai
      • Shanghai, Shanghai, Kina, 200032
        • Zhongshan Hospital Fudan University
      • Shanghai, Shanghai, Kina, 200080
        • Shanghai First People's Hospital
    • Shanxi
      • Xian, Shanxi, Kina, 710061
        • First Affiliated Hospital Of Medical College of Xian Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital,Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • The First Affiliated Hospital, Zhejiang University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

male and female kidney transplantation patients with living-donor grafts, > 18 years of age

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
kidney transplantation patients with living-donor grafts

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Graft survival
Tidsramme: 5-year
Graft survival, measured as the time between kidney transplant and the failure of the graft.
5-year
Recipient survival
Tidsramme: 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.
5-year

Sekundære resultatmål

Resultatmål
Tidsramme
Average creatinine value
Tidsramme: 5 years
5 years
The rate of acute rejection episodes
Tidsramme: 5 years
5 years
The incidence of BPAR and its severity
Tidsramme: 5 years
5 years
The incidence of NODM
Tidsramme: 5 years
5 years
The incidence of infection
Tidsramme: 5 years
5 years
The incidence of biopsy proven CNIs nephrotoxicity
Tidsramme: 5 years
5 years
The rate of posttransplantation malignancies
Tidsramme: 5 years
5 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2012

Primær færdiggørelse (Faktiske)

1. august 2013

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

16. februar 2013

Først indsendt, der opfyldte QC-kriterier

20. februar 2013

Først opslået (Skøn)

22. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. juni 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • COLO400ACN02

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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