Unique ID issued by UMIN | UMIN000009472 |
---|---|
Receipt number | R000011078 |
Scientific Title | Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease |
Date of disclosure of the study information | 2012/12/04 |
Last modified on | 2017/12/07 11:12:02 |
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Investigation of responses to erythropoiesis stimulating agents (ESA) for the initial treatment of renal anemia in patients with chronic kidney disease
Japan |
Renal anemia in chronic kidney disease
Medicine in general | Nephrology |
Others
NO
To investigate the response to rHuEPO or epoetin beta pegol for the treatment of renal anemia in patients with chronic kidney disease
Efficacy
Exploratory
Pragmatic
Not applicable
(1)Comparison of changes in hepcidin concentrations between patients treated with rHuEPO or those treated with epoetin beta pegol
(2)Identification of factors affecting the treatment response to rHuEPO or epoetin beta pegol
(1)Effects of rHuEPO and epoetin beta pegol on iron metabolism
(2)Changes in dosage of epoetin beta pegol and Hb level
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
YES
Institution is not considered as adjustment factor.
2
Treatment
Medicine |
CERA Group:
Epoetin beta pegol is subcutaneously administered once every two weeks.
rHuEPO Group:
rHuEPO is subcutaneously administered once every two weeks.
20 | years-old | <= |
Not applicable |
Male and Female
(1)Patients with no prior treatment with ESA
(2)Patients 20 years old or older at time of study initiation
(3)Patients with a hemoglobin (Hb) level of >= 8 g/dL and < 11 g/dL
(4)Patients with eGFR of < 60 mL/min/1.73m2
(5)Patients who give written informed consent
(1)Patients on hemodialysis or peritoneal dialysis
(2)Patients who underwent renal transplant
(3)Patients with malignancy or hematological diseases (such as MDS)
(4)Patients with severe complications, such as severe infections
(5)Patients who take iron therapy
(6)Patients who are judged to be ineligible by an attending doctor
40
1st name | |
Middle name | |
Last name | Koji Mitsuiki |
Fukuoka Red Cross Hospital
Division of Nephrology
3-1-1 Ohgusu, Minami-ku, Fukuoka
092-551-1211
koji@fukuoka-med.jrc.or.jp
1st name | |
Middle name | |
Last name | Koji Mitsuiki |
Fukuoka Red Cross Hospital
Division of Nephrology
3-1-1 Ohgusu, Minami-ku, Fukuoka
092-551-1211
koji@fukuoka-med.jrc.or.jp
Fukuoka Red Cross Hospital
Fukuoka Red Cross Hospital, Kyushu University
Self funding
NO
福岡赤十字病院(福岡県),九州大学(福岡県),宗像医師会病院(福岡県),九州医療センター(福岡県),原三信病院(福岡県),福岡東医療センター(福岡県),浜の町病院(福岡県),白十字病院(福岡県),小倉記念病院(福岡県),飯塚病院(福岡県),掖済会門司病院(福岡県),製鉄記念八幡病院(福岡県),聖マリア病院(福岡県)
2012 | Year | 12 | Month | 04 | Day |
Unpublished
Open public recruiting
2012 | Year | 05 | Month | 18 | Day |
2012 | Year | 12 | Month | 05 | Day |
2016 | Year | 06 | Month | 03 | Day |
2016 | Year | 06 | Month | 03 | Day |
2016 | Year | 06 | Month | 03 | Day |
2017 | Year | 12 | Month | 07 | Day |
2012 | Year | 12 | Month | 03 | Day |
2017 | Year | 12 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011078