Unique ID issued by UMIN | C000000255 |
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Receipt number | R000000311 |
Scientific Title | Additional JET Study for Patients during Maintenance Phase(Co-JET Study) |
Date of disclosure of the study information | 2005/10/01 |
Last modified on | 2016/07/14 18:40:10 |
Additional JET Study for Patients during Maintenance Phase(Co-JET Study)
Co-JET Study
Additional JET Study for Patients during Maintenance Phase(Co-JET Study)
Co-JET Study
Japan |
maintenance-phase renal failure (predialysis renal failure)
Medicine in general | Cardiology | Endocrinology and Metabolism |
Hematology and clinical oncology | Nephrology | Urology |
Others
NO
To investigate the effects of erythropoietin therapy on vital prognosis and hospitalization during the maintenance phase for anemia and renal failure management and therapy.
Efficacy
Risk analysis of background factors affecting vital prognosis following initiation of hemodialysis is performed by the appropriate technique, such as Cox's regression model.
Additionally, the same analysis is carried out with hospitalization as is done for vital prognosis.
Observational
Not applicable |
Not applicable |
Male and Female
All patients consenting to the present study of those registered in the Japan Erythropoietin Treatment Study for Target Hb and Survival (JET Study).
no criteria
3000
1st name | |
Middle name | |
Last name | SYUNJI YOKOYAMA |
Chugai Pharmaceutical CO.LTD.
Drug Safety Unit
1-1MUROMACHI 2-CHOME, CHUO-KU TOKYO #103-8324, JAPAN
03-3273-0773
udagawayko@chugai-Pharm.co.jp
1st name | |
Middle name | |
Last name | SHIGERU NIHOJIMA |
Chugai Pharmaceutical CO.LTD.
PHARMACOVIGILANCE Dept.
1-1MUROMACHI 2-CHOME, CHUO-KU TOKYO #103-8324, JAPAN
03-3273-0773
http://www.chugai-pharm.co.jp
nihojimasgr@chugai-pharm.co.jp
Scientific Advisory Committee (SAC)
CHUGAI PHARMACEUTICAL CO.LTD.
Self funding
NO
2005 | Year | 10 | Month | 01 | Day |
http://www.chugai-pharm.co.jp
Partially published
Among registration cases, We were analysis on primary endpoint about 3,286 cases that a CRF was collected at dosage start time by Mar.,2009.
3,280 patients after 6 patients were excluded as not eligible for analysis on the effects of treatment with rHuEPO on 1 y survival after beginning HD.As this result, in the rHuEPO treated group compared to the non-treatment group cumulative survivors were significantly higher, 98.59%, 97.10% and 95.36%, at 3, 6 and 12 mo after onset of HD, respectively.And the results were univariate analysis HR=0.47 (95%CI 0.34-0.64) and adjusted multivariate analysis HR=0.61 (95%CI 0.42-0.87).
2,434 patients after 852 patients were excluded as not eligible for analysis on the effect of rHuEPO treatment prior to HD on time to onset of HD .Effective covariates on the motivation to start rHuEPO treatment (IPW method) was seen in patients with higher sCre, greater age, hypertension or diabetes had a tendency to be treated with rHuEPO and patients with higher Hb or heart failure had a tendency to not be treated with rHuEPO.The adjusted hazard ratio of rHuEPO treatment on progression of CKD during the preHD period using IPW methods was 0.63 (95%CI 0.53–0.76; p<0.0001). Since stable weights could not be obtained with this analysis, a sensitivity analysis was performed. As a result, the hazard ratio appeared to be lower than 0.63.
Influence of rHuEPO treatment before HD on progression of CKD using K-M method was also performed and the results were as univariate analysis HR=0.46 (95%CI 0.42-0.51) and adjusted multivariate analysis HR=0.27 (95%CI 0.22-0.33).
Completed
2005 | Year | 06 | Month | 10 | Day |
2005 | Year | 10 | Month | 01 | Day |
2008 | Year | 09 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
(1) Risk analysis of background factors affecting vital prognosis following initiation of hemodialysis is performed by the appropriate technique, such as Cox's regression model. Additionally, the same analysis is carried out with hospitalization as is done for vital prognosis.
(2) The relationship of the start of erythropoietin preparation during the maintenance phase to the disease state at the initiation of dialysis or renal anemia is investigated. Additionally, a risk analysis is conducted to assess prognostic factors(Hb during maintenance phase and manner and duration of the treatment for maintenance-phase renal failure) after initiation of dialysis.
(3) Shifts in clinical laboratory test findings before the initiation of hemodialysis are tabulated in figures and tables and analyzed appropriately.
2005 | Year | 09 | Month | 30 | Day |
2016 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000311
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