Unique ID issued by UMIN | UMIN000013464 |
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Receipt number | R000015164 |
Scientific Title | oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa |
Date of disclosure of the study information | 2014/04/01 |
Last modified on | 2019/09/26 12:13:07 |
oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa
BRIGHTEN
oBservational clinical Research In chronic kidney disease patients with renal anemia :renal proGnosis in patients with Hyporesponsive anemia To Erythropoiesis stimulating agents,darbepoetiN alfa
BRIGHTEN
Japan |
Renal anemia in chronic kidney disease
Nephrology |
Others
NO
This is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.
Efficacy
Deterioration of renal function,
Cardiovascular disease events
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who are planning to start treatment with darbepoetin alfa within
8 weeks after enrollment;
2) Patients with eGFR <60 mL/min/1.73m2 at the latest examination performed within 8 weeks before enrollment;
3) Patients with a hemoglobin level <11.0 g/dL at the latest examination performed within 8 weeks before enrollment;
4) Patients aged at least 20 years or older at the time of providing informed consent;
5) Patients who voluntarily provided written informed consent to participate in the study.
1) Patients who are planning to start hemodialysis or renal transplantation within 24 weeks after enrolment;
2) Patients with a history of treatment with ESA except the ones who were
treated temporarily more than 12 weeks before the enrollment;
3)Patients with malignant tumor, hematological disease, or hemorrhagic lesions;
4) Patients with hypersensitivity to ESA or any ingredient thereof;
5) Pregnant, lactating or possibly pregnant women or those who wish to be pregnant during the study period;
6) Patients who are participating in other clinical study;
7) Patients who are assessed as not eligible for the study by the investigator.
2000
1st name | Ichiei |
Middle name | |
Last name | Narita |
Niigata University Graduate School of Medical & Dental Sciences
Division of Clinical Nephrology & Rheumatology
951-8510
1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, Japan
025-227-2200
naritai@med.niigata-u.ac.jp
1st name | Tomoko |
Middle name | |
Last name | Usui |
The University of Tokyo Hospital
Division of Nephrology and Endocrinology
113-8655
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
usu-tky@umin.ac.jp
Niigata University Graduate School of Medical & Dental Sciences
Kyowa Kirin Co., Ltd.
Profit organization
Foundation for Biomedical Research and Innov
ation at Kobe
Niigata University Medical & Dental Hospital IRB
1-757 Asahimachi-dori, Chuo-ku, Niigata, Niigata, Japan
025-227-2436
chiken@med.niigata-u.ac.jp
NO
NCT02136563
ClinicalTrials.gov
2014 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2014 | Year | 05 | Month | 02 | Day |
2014 | Year | 05 | Month | 02 | Day |
2014 | Year | 05 | Month | 02 | Day |
2018 | Year | 09 | Month | 30 | Day |
prospective, multicenter, observational study
2014 | Year | 03 | Month | 19 | Day |
2019 | Year | 09 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015164
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