Clinical Trial: A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypopar

Brief Summary: This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.

Detailed Summary: Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for up to 80 months, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.
Sponsor: Shire

Current Primary Outcome:

  • Demonstrate the long-term safety of subcutaneous (SC) NPSP558 (rhPTH[1-84]) [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Demonstrate the long-term tolerability of subcutaneous (SC) NPSP558 (rhPTH[1-84]) [ Time Frame: up to 80 months of treatment, 4 weeks of follow-up ]


Original Primary Outcome:

  • A reduction in oral calcium or an oral calcium dose of ≤ 500 mg [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]
  • A reduction in oral calcitriol to ≤ 0.25 μg [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]
  • An albumin-corrected total serum calcium concentration that is normalized or maintained compared to the baseline value (≥7.5 mg/dL) and ULN [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]


Current Secondary Outcome:

  • Evaluate the impact of different preparations of calcium on the response to rhPTH[1-84] replacement therapy [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Demonstrate that dosing with rhPTH[1-84] across a dose range of 25 to 100 μg SC can be implemented in a safe and effective manner and can be maintained throughout long-term treatment [ Time Frame: Up to 80 months of treatment, 4 weeks of follow-up ]
  • Evaluate the impact of calcium-sparing diuretics on serum and urinary calcium [ Time Frame: 52 weeks of treatment, 4 weeks of follow-up ]


Original Secondary Outcome:

Information By: Shire

Dates:
Date Received: February 11, 2011
Date Started: April 2011
Date Completion: January 2018
Last Updated: February 1, 2017
Last Verified: February 2017