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A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Investigate the Use of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]) for the Treatment of Adults With Hypoparathyroidism

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2022

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At a glance

  • Drugs Parathyroid hormone (Primary)
  • Indications Hypoparathyroidism
  • Focus Registrational; Therapeutic Use
  • Acronyms REPLACE
  • Sponsors NPS Pharmaceuticals
  • Most Recent Events

    • 26 Aug 2022 Results (n=248) assessing the changes in estimated glomerular filtration rate over a 5-year period in adult patients with chronic hypoparathyroidism treated with recombinant parathyroid hormone (1-84), rhPTH(1-84), compared with a historical control cohort of patients who did not receive rhPTH(1-84) from REPLACE (NCT00732615), RELAY (NCT01268098), RACE (NCT01297309), and HEXT (NCT01199614 and continuation study NCT02910466) studies, published in the Advances in Therapy.
    • 11 Jun 2022 Results of a retrospective cohort study assessing risk of cardiovascular events using patients data from three clinical studies: REPLACE, RELAY and RACE and compared with a historical control cohort (selected from IBM Explorys electronic medical record database; Jan 2007-Aug 2019) of patients not treated with rhPTH(1-84) published in the Advances in Therapy
    • 23 Mar 2021 Results of comparative analysis with a historical control cohort with patients data pooled from NCT00732615 (REPLACE), NCT01268098 (RELAY), NCT01297309 (RACE) and NCT01199614 (HEXT) clinical trials assessing the chronic kidney disease (CKD) outcomes over a period of up to 5 years in adult patients with chronic hypoparathyroidism treated with recombinant human parathyroid hormone presented at the 103rd Annual Meeting of the Endocrine Society
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