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| autoid | 120 |
| crg_id | CRG0306000048 |
| titleoftrial | Randomized-controlled,open label, dose-finding parallel study of Darbepoetin alfa (KRN321)for the maintenance treatment of anemia in Pre-Dialysis Patients |
| acronymnoftrial | |
| website | |
| identificationno | KRN321-SC/04-A07, A08 |
| leadprefix | Dr |
| leadsurname | Akizawa |
| leadgivennames | Tadao |
| leadposition | Professor |
| leaddepartment | Department of Nephrology |
| leadorganisation | Showa University School of Medicine |
| leadaddress | 5-8, Hatanodai 1-chome, Shinagawa-ku, Tokyo, Japan |
| leademail | akizawa@med.showa-u.ac.jp |
| leadphone | +81 3 3784 8000 |
| leadfax | +81 3 3784 3751 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
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| funding | industry |
| otherfunding | |
| fundingnameofsponsors | Kirin Brewery Co., Ltd. |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | 05/2004 |
| actualstart | 07/2004 |
| proposedcompletiondate | 12/2006 |
| actualcompletiondate | 12/2005 |
| multi_center_study | yes |
| numberofcentres | 51-55 |
| multi_national_study | no |
| countrycentres | Japan |
| researchquestion | To evaluate the efficacy and safety of Darbepoetin alfa (KRN321) in Pre-Dialysis Patients with anemia. |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | Pre-Dialysis Patients with anemia |
| intervention1 | Darbepoetin alfa (KRN321) once every 2 weeks or once every 4 weeks. |
| intervention2 | Epoetin alfa(KRN5702) once per week or once every 2 weeks. |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | 80 year > or = age > or = 20 years |
| totalrecruitment | 210 |
| inclusion | 1.Pre-Dialysis Patients
2.Hb < 10.0 g/dL 3.serum creatinin > or = 2.0 mg/dL |
| exclusion | Not willing or unable to participate |
| primaryoutcomes | The rise in Hb concentration during the first dosing of Darbepoetin alfa (KRN321) to once every 2 weeks administration. |
| secondaryoutcomes | 1.The target Hb concentration achievement rate and maintenance rate.
Additional investigation As exploratory research, relatiomship between improvement of anemia(Hb level) and improvement of QOL or Cardiac function . |
| reference |