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| autoid | 131 |
| crg_id | CRG030600060 |
| titleoftrial | Randomized, double-blind, placebo-controlled study of KRN1493(cinacalcet HCl) in hemodialysis patients with secondary hyperparathyroidism (HPT) |
| acronymnoftrial | |
| website | http:// |
| identificationno | KRN1493/04-A10 |
| 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 | |
| contactphone | |
| contactfax | |
| funding | industry |
| otherfunding | |
| fundingnameofsponsors | Kirin Brewery Co., Ltd. |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | yes |
| blinding_investigators | yes |
| blinding_outcomes | yes |
| blinding_analysts | yes |
| proposedstart | 03/2004 |
| actualstart | 04/2004 |
| proposedcompletiondate | 06/2005 |
| actualcompletiondate | 12/2004 |
| multi_center_study | yes |
| numberofcentres | 26_30 |
| multi_national_study | no |
| countrycentres | Japan |
| researchquestion | To evaluate the efficacy and safety of KRN1493(cinacalcet HCl) in hemodialysis patients with secondary HPT |
| study_status_recruitment | no_longer_recruiting |
| study_status_recruitment_follow | completed |
| healthcarecondition | Hemodialysis patients with secondary HPT |
| intervention1 | KRN1493(cinacalcet HCl) or placebo once daily |
| intervention2 | |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | Greater than or equal to 20 years of age |
| totalrecruitment | 143 |
| inclusion | 1.Patients with chronic kidney disease receiving hemodialysis for > or = 16 weeks
2.Serum intact PTH > or = 300 pg/mL 3.Corrected serum calcium > or = 9.0 mg/dL |
| exclusion | Not willing or unable to participate |
| primaryoutcomes | Proportion of subjects with serum intact PTH < or = 250 at the end of the study |
| secondaryoutcomes | 1.Proportion of subjects with > or = 30% reduction from baseline in serum intact PTH at the end of the study
2.Serum Ca x P product at the end of the study 3.Bone metabolism markers (BALP, TRACP, Osteocalcin) at the end of the study |
| reference |