Unique ID issued by UMIN | UMIN000006661 |
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Receipt number | R000007872 |
Scientific Title | Clinical study to evaluate the efficacy and safety of darbepoetin-alfa in kidney transplant recipients with erythropoietin-resistant anemia |
Date of disclosure of the study information | 2011/12/01 |
Last modified on | 2017/05/22 17:37:40 |
Clinical study to evaluate the efficacy and safety of darbepoetin-alfa in kidney transplant recipients with erythropoietin-resistant anemia
Darbepoetin-alfa for erythropoietin-resistant post transplant anemia
Clinical study to evaluate the efficacy and safety of darbepoetin-alfa in kidney transplant recipients with erythropoietin-resistant anemia
Darbepoetin-alfa for erythropoietin-resistant post transplant anemia
Japan |
Post-transplantation anemia
Nephrology | Urology |
Others
NO
To evaluate the efficacy and safety of darbepoetin-alfa for erythropoietin-resistant anemia in kidney transplant recipients
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1.Mean hemoglobin level at the end of the study.
2.Percentage of patients with hemoglobin level within the target range of 11 to 13 g/dL at the end of the study
1.Dose of darbepoetin-alfa
2.Changes in estimated glomerular filtration rate
3.Changes in blood pressure
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Darbepoetin-alfa for 6-12 months
Not applicable |
Not applicable |
Male and Female
1.Kidney transplant patients
2.Patients who have continued EPO treatment for more than three months
3.Patients who have hemoglobin <11g/dL in spite of EPO treatment
1.Patients with active infection or malignancy
2.Patients who receive surgical management
40
1st name | |
Middle name | |
Last name | Siro Takahara |
Osaka University Graduate School of Medicine
Department of Advanced Technology for Transplant
2-2 Yamada-oka, Suita, Osaka
06-6879-3746
kakuta@uro.med.osaka-u.ac.jp
1st name | |
Middle name | |
Last name | Kakuta Yoichi |
Osaka University Graduate School of Medicine
Department of Specific Organ Regulation (Urology)
2-2 Yamada-oka, Suita, Osaka
06-6879-3531
kakuta@uro.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine
None
Self funding
NO
大阪大学医学部附属病院(大阪府)
蒼龍会井上病院(大阪府)
2011 | Year | 12 | Month | 01 | Day |
Unpublished
Terminated
2011 | Year | 10 | Month | 13 | Day |
2011 | Year | 12 | Month | 01 | Day |
2017 | Year | 05 | Month | 22 | Day |
2017 | Year | 05 | Month | 22 | Day |
2017 | Year | 05 | Month | 22 | Day |
2017 | Year | 05 | Month | 22 | Day |
2011 | Year | 11 | Month | 02 | Day |
2017 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007872
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