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

17 juni 2014 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

1500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Retrospektiv

Kohorter och interventioner

Grupp / Kohort
kidney transplantation patients with living-donor grafts

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Graft survival
Tidsram: 5-year
Graft survival, measured as the time between kidney transplant and the failure of the graft.
5-year
Recipient survival
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2012

Primärt slutförande (Faktisk)

1 augusti 2013

Avslutad studie (Faktisk)

1 augusti 2013

Studieregistreringsdatum

Först inskickad

16 februari 2013

Först inskickad som uppfyllde QC-kriterierna

20 februari 2013

Första postat (Uppskatta)

22 februari 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

18 juni 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 juni 2014

Senast verifierad

1 juni 2014

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • COLO400ACN02

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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3
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