Unique ID issued by UMIN | UMIN000008568 |
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Receipt number | R000010042 |
Scientific Title | Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis |
Date of disclosure of the study information | 2012/07/31 |
Last modified on | 2018/10/17 15:25:37 |
Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis
MIRACLE-CKD
Post-marketing surveillance study of MIRCERA on renal survival in CKD patients not on dialysis
MIRACLE-CKD
Japan |
Renal anemia associated with chronic kidney disease(CKD) not on dialysis
Nephrology |
Others
NO
The main objective of this study is to investigate the relation between maintenance hemoglobin levels and renal survival during MIRCERA administration to treat renal anemia in CKD patients not on dialysis.
Safety
Renal survival defined the periods until the earliest days occurred one of the three composite events;
1)renal replacement therapy
2)doubling of serum creatinine
3)eGFR less than 6.0mL/min/1.73m2
Observational
Not applicable |
Not applicable |
Male and Female
CKD patients not on dialysis associated with renal anemia, and
1)MIRCERA-naïve patients with the hemoglobin level less than 11g/dL
2)patients estimated not to introduce
dialysis for at least six months after starting MIRCERA administration
1)patients with anemia by other than renal anemia, such as by overt hemorrhage, by hematological disorders (leukemia, malignant lymphoma, myelodysplastic syndrome, or aplastic anemia, and others), and patients undergoing myelosuppressive treatment (chemotherapy or radiation therapy)
2)patients within one year after kidney transplantation
3)patients with eGFR of less than 6mL/min/1.73m2
5000
1st name | |
Middle name | |
Last name | JOJI MOCHIZUKI |
CHUGAI PHARMACEUTICAL CO., LTD.
PHARMACOVIGILANCE DEPT.
2-1-1 NIHONBASHI-MUROMACHI, CHUO-KU,
03-3273-0769
mochizukijuj@chugai-pharm.co.jp
1st name | |
Middle name | |
Last name | IZUMI KAWASHIMA |
CHUGAI PHARMACEUTICAL CO., LTD.
PHARMACOVIGILANCE DEPT.
2-1-1 NIHONBASHI-MUROMACHI, CHUO-KU,
03-3273-0769
kawashimaizm@chugai-pharm.co.jp
CHUGAI PHARMACEUTICAL CO., LTD.
CHUGAI PHARMACEUTICAL CO., LTD.
Self funding
NO
2012 | Year | 07 | Month | 31 | Day |
Published
https://rd.springer.com/article/10.1007/s10157-018-1649-0
In a multicenter prospective observational study, Japanese NDCKD patients with an estimated glomerular filtration rate (eGFR) of >=6 mL/min/1.73 m2 and renal anemia (Hb <11 g/dL) treated with epoetin beta pegol (C.E.R.A.) for the first time were divided into 2 groups by Hb level (<11 g/dL or >=11 g/dL) in Week 12 of C.E.R.A. treatment (Week 12 Hb). Renal outcome was defined as time until first occurrence of one of the following: progression to renal replacement therapy, serum creatinine doubling, or eGFR falling below 6 mL/min/1.73 m2. The effect of Week 12 Hb on the onset of renal events was assessed by Kaplan-Meier and multivariate Cox regression analyses.
In the landmark analysis included 2851 patients, Kaplan-Meier renal survival rate was 37.57% in the <11 g/dL group and was significantly higher (51.47%) in the >=11 g/dL group (P<0.0001). Multivariate Cox regression analysis revealed significantly higher risk of renal events in the <11 g/dL group than in the >=11 g/dL group (hazard ratio: 1.26; 95% confidence interval: 1.05-1.51; P=0.0103).
The results suggest that Week 12 Hb levels >=11 g/dL achieved with C.E.R.A. treatment were associated with better renal outcomes than Hb levels <11 g/dL.
Completed
2012 | Year | 04 | Month | 13 | Day |
2012 | Year | 08 | Month | 01 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 09 | Month | 30 | Day |
2017 | Year | 03 | Month | 31 | Day |
2017 | Year | 09 | Month | 30 | Day |
The relation between maintenance hemoglobin levels and renal survival during MIRCERA administration will be analyzed as follows;
1)renal survival will be estimated bu using Kaplan-Meier method.
2)adjusted hazard ratio will be estimated by stratification of hemoglobin levels at three month after starting MIRCEA administaration(Landdmark analysis).
3)adjusted hazard ratio will be estimated by stratification of periods over 11 g/dL of hemoglobin level during one year after starting MIRCEA administaration.
4)hazard ratio will be estimated by using several suitable analytical methods including an inverse probability weighted (IPW) Cox model.
5)the relation between maintenance hemoglobin levels and change rate of eGFR will also be evaluated.
2012 | Year | 07 | Month | 30 | Day |
2018 | Year | 10 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010042
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