Clinical Trial: Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single-dose Phase 1 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Peritoneal Dialysis

Brief Summary: This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.

Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd

Current Primary Outcome: Number and types of adverse events [ Time Frame: For 8 days ]

The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram


Original Primary Outcome: Same as current

Current Secondary Outcome: Profiles of pharmacokinetics [ Time Frame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose ]

intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin


Original Secondary Outcome: Same as current

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: May 14, 2014
Date Started: May 2014
Date Completion:
Last Updated: March 3, 2015
Last Verified: March 2015