- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01796639
Retrospective Study of Long-term Survival and Related Factors Among Kidney Transplant Recipients in China (REACH)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Beijing
-
Beijing, Beijing, Čína, 100034
- Peking University First Hospital
-
Beijing, Beijing, Čína, 100853
- Chinese PLA General Hospital
-
Beijing, Beijing, Čína, 100000
- The 309th Hospital of Chinese People's Liberation Army
-
Beijing, Beijing, Čína, 100020
- Beijing Chaoyang Hospital
-
Beijing, Beijing, Čína, 100050
- Beijing Friendship Hospital
-
-
Fujian
-
Fuzhou, Fujian, Čína, 350025
- Fuzhou General hospital of Nanjing Military Command
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510080
- The First Affiliated Hospital Sun Yat-Sen University
-
Guangzhou, Guangdong, Čína, 510599
- Nanfang Hospital
-
-
Henan
-
Zhengzhou, Henan, Čína, 450052
- The First Affiliated Hospital of Zhengzhou University
-
-
Hubei
-
Wuhan, Hubei, Čína, 430030
- Tongji Hospital
-
-
Hunan
-
Changsha, Hunan, Čína, 410000
- The second Xiangya Hospital of Central South University
-
-
Liaoning
-
Shenyang, Liaoning, Čína
- Shenyang Military General Hospital
-
-
Shandong
-
Jinan, Shandong, Čína, 250000
- Jinan Military General Hospital
-
-
Shanghai
-
Shanghai, Shanghai, Čína, 200032
- Zhongshan Hospital Fudan University
-
Shanghai, Shanghai, Čína, 200080
- Shanghai First People's Hospital
-
-
Shanxi
-
Xian, Shanxi, Čína, 710061
- First Affiliated Hospital Of Medical College of Xian Jiaotong University
-
-
Sichuan
-
Chengdu, Sichuan, Čína, 610041
- West China Hospital,Sichuan University
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310003
- The First Affiliated Hospital, Zhejiang University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Retrospektivní
Kohorty a intervence
Skupina / kohorta |
---|
kidney transplantation patients with living-donor grafts
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Graft survival
Časové okno: 5-year
|
Graft survival, measured as the time between kidney transplant and the failure of the graft.
|
5-year
|
Recipient survival
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Average creatinine value
Časové okno: 5 years
|
5 years
|
The rate of acute rejection episodes
Časové okno: 5 years
|
5 years
|
The incidence of BPAR and its severity
Časové okno: 5 years
|
5 years
|
The incidence of NODM
Časové okno: 5 years
|
5 years
|
The incidence of infection
Časové okno: 5 years
|
5 years
|
The incidence of biopsy proven CNIs nephrotoxicity
Časové okno: 5 years
|
5 years
|
The rate of posttransplantation malignancies
Časové okno: 5 years
|
5 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- COLO400ACN02
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .