Clinical Trial: A Study of KRN23 in Subjects With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients With Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome
Brief Summary: The purpose of the study is to evaluate the efficacy and safety of KRN23 after its 48-week once every 4 weeks repeated subcutaneous administration to Japanese and Korean patients with Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome by a multicenter, open-label, intraindividual dose adjustment study
Detailed Summary:
Sponsor: Kyowa Hakko Kirin Co., Ltd
Current Primary Outcome: serum phosphorus concentration at each test time point [ Time Frame: up to week 48 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- change from baseline in alkaline phosphatase [ Time Frame: up to week 48 ]
- change from baseline in 1,25(OH)2D [ Time Frame: up to week 48 ]
- change from baseline in urine P [ Time Frame: up to week 48 ]
- change from baseline in tubular reabsorption of phosphate [ Time Frame: up to week 48 ]
- change from baseline in ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate [ Time Frame: up to week 48 ]
- change from baseline in skeletal disease/osteomalacia through trans-iliac crest bone biopsy [ Time Frame: up to week 48 ]
- Effect to Sit to Stand (STS) test [ Time Frame: up to week 48 ]
- Effect to Hand Held Dynamometry (HHD) [ Time Frame: up to week 48 ]
- Effect to Weighted Arm Lift (WAL) test [ Time Frame: up to week 48 ]
- Effect to 6 minute walking test (6MWT) [ Time Frame: up to week 48 ]
- Effect to patient reported outcomes [ Time Frame: up to week 48 ]
- maximum concentration (Cmax) of KRN23 [ Time Frame: up to week 48 ]
- area under the curve (AUC) of KRN23 [ Time Frame: up to week 48 ]
- half-life (t1/2) of KRN23 [ Time Frame: up to week 48 ]
Original Secondary Outcome: Same as current
Information By: Kyowa Hakko Kirin Co., Ltd
Dates:
Date Received: March 7, 2016
Date Started: April 2016
Date Completion: July 2017
Last Updated: December 5, 2016
Last Verified: December 2016