Unique ID issued by UMIN | UMIN000008984 |
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Receipt number | R000010517 |
Scientific Title | Protective effect of kidney by low dose of darbepoetin alfa in patients with chronic kidney disease |
Date of disclosure of the study information | 2012/09/30 |
Last modified on | 2012/09/26 14:22:15 |
Protective effect of kidney by low dose of darbepoetin alfa in patients with chronic kidney disease
Protective effect of kidney by low dose of darbepoetin alfa in patients with chronic kidney disease
Protective effect of kidney by low dose of darbepoetin alfa in patients with chronic kidney disease
Protective effect of kidney by low dose of darbepoetin alfa in patients with chronic kidney disease
Japan |
Chronic kidney disaese
Nephrology |
Others
NO
The purpose of verifying whether darbepoetin alpha indicates the renal protective effect directly without showing the correction of anemia
Efficacy
Exploratory
Phase II
Differences in rate of decline of eGFR at the time of 6 months in the treatment groups and the non-treated group of darbepoetin
Changes in serum creatinine, urine protein content, NAG, the concentration of Hemoglobin
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
darbepoetin alfa
Only iron supplementation
20 | years-old | <= |
85 | years-old | >= |
Male and Female
Patients with chronic kidney disease(eGFR15-60ml/min),with renal anemia(hemoglobin concentration 9-11g/dl),and has never been administered in the past the formulation ESA. Patients with above conditions are met, consent was obtained from the person with sufficient explanation.
Excluded patients with hypertension uncontrolled, congestive heart failure, surgery with massive bleeding within 16 weeks, blood disorders and malignancies, with patients treated with Doosan Mepichiosutan Henin and anabolic hormone and testosterone within 16 weeks, drug allergy, collagen disease and vasculitis, and patients who received a blood transfusion within 16 weeks.
40
1st name | |
Middle name | |
Last name | Ogawa Makoto |
Graduate shcool of medicine, Chiba university
Department of medicine and clinical oncology
1-8-1 Inohana chuoku, chiba city, Chiba, Japan
1st name | |
Middle name | |
Last name |
Chiba university hospital
Nephrology
1-8-1 Inohana chuoku, chiba city, Chiba, Japan
Chiba university hospital, Nephrology
None
Other
NO
千葉大学附属病院(千葉県)
2012 | Year | 09 | Month | 30 | Day |
Unpublished
Preinitiation
2012 | Year | 06 | Month | 20 | Day |
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 09 | Month | 26 | Day |
2012 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010517
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