Clinical Trial: Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

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

Official Title: A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis

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

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

Current Primary Outcome: The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination [ Time Frame: For 19 weeks ]

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


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 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period ]
    Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed.
  • Profiles of pharmacodynamics [ Time Frame: For 4-15 days after every dosing ]
    intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin


Original Secondary Outcome: Same as current

Information By: Kyowa Hakko Kirin Co., Ltd

Dates:
Date Received: September 2, 2013
Date Started: August 2013
Date Completion:
Last Updated: February 28, 2017
Last Verified: February 2017