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| autoid | 122 |
| crg_id | CRG0306000050 |
| titleoftrial | Multicentre, open-label, single-arm study of Darbepoetin alfa (KRN321) intravenously administration with end stage renal failure on Peritoneal dialysis |
| acronymnoftrial | |
| website | |
| identificationno | KRN321/03-A09 |
| leadprefix | Dr |
| leadsurname | Hiramatsu |
| leadgivennames | Makoto |
| leadposition | Director |
| leaddepartment | Department of Nephrology |
| leadorganisation | Okayama Saiseikai General Hospital |
| leadaddress | 1-17-18, Ifuku-cho, Okayama, Japan |
| leademail | m-hirama@td5.so-net.ne.jp |
| leadphone | +81 86 252 2211 |
| leadfax | +81 86 252 6882 |
| leadsuffix | |
| contactprefix | |
| contactsurname | |
| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
| contactaddress | |
| contactemail | |
| contactphone | |
| contactfax | |
| funding | industry |
| otherfunding | |
| fundingnameofsponsors | Kirin Brewery Co., Ltd. |
| ethicsapproval | yes |
| studytype | nonrandomised |
| studytype_other | Open labelled single arm study |
| groupassignment | |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | no |
| proposedstart | 06/2003 |
| actualstart | 07/2003 |
| proposedcompletiondate | 11/2004 |
| actualcompletiondate | 06/2004 |
| multi_center_study | yes |
| numberofcentres | 14 |
| multi_national_study | no |
| countrycentres | Japan |
| researchquestion | To evaluate the efficacy and safety of Darbepoetin alfa (KRN321) intravenously administration with end stage renal failure on peritoneal dialysis |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | Peritoneal dialysis patients with renal anemia |
| intervention1 | Darbepoetin alfa (KRN321) once per week |
| intervention2 | Darbepoetin alfa (KRN321) once every 2 or 4 weeks |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | age > or = 20 years |
| totalrecruitment | 87 |
| inclusion | 1.Patients with chronic kidney disease receiving peritoneal dialysis
2-1(rHuEPO-naive patients). Hb concentration < 10.0 g/dL 2-2(rHuEPO-receiving patients). Hb concentration ranging from 9.0 g/dL to 12.0 g/dL |
| exclusion | Not willing or unable to participate |
| primaryoutcomes | Hb concentration |
| secondaryoutcomes | 1.The rise in Hb concentration during the first 4 weeks after the first dosing of KRN321 in the rHuEPO-naive patients
2.The target Hb concentration maintenance rate 3.The therapeutic Hb concentration maintenance rate (4.Maintenance dose and frequency of administration) |
| reference |