Clinical Trial: Hypophosphatemia With Intravenous Ferric Carboxymaltose Versus Iron Dextran in Women With Iron Deficiency Secondary to Heavy Uterine Bleeding

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Randomized, Controlled Study to Investigate the Safety and Explore the Mechanism of Hypophosphatemia With Intravenous Ferric Carboxymaltose (FCM) Versus Iron Dextran in

Brief Summary: The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose [FCM]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Detailed Summary:
Sponsor: Luitpold Pharmaceuticals

Current Primary Outcome:

  • Changes in blood markers of phosphate and bone metabolism following intravenous (IV) administration of FCM in order to explore the mechanism of asymptomatic hypophosphatemia previously observed to follow administration of FCM. [ Time Frame: Day 0, Day 1, Day 7, Day 14, and Day 35 ]
    Blood markers include phosphate, calcium, vitamin D, creatinine, and PTH.
  • Changes in urine markers of phosphate and bone metabolism following intravenous (IV) administration of FCM in order to explore the mechanism of asymptomatic hypophosphatemia previously observed to follow administration of FCM. [ Time Frame: Day 0, Day 1, Day 7, Day 14, and Day 35 ]
    Urine markers include phosphate, calcium, creatinine, albumin, and amino acids.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of subjects achieving a hemoglobin increase > or = to 2 g/dL. [ Time Frame: Anytime between baseline and end of study or time of intervention ]
  • Percent of subjects with treatment-emergent adverse events. [ Time Frame: Anytime after study drug infusion between baseline (Day 0) through end of study (Day 35) or 30 days after last dose of study drug (whichever is longer) ]
  • Occurrence of treatment-emergent serious adverse events. [ Time Frame: Anytime after study drug infusion between baseline (Day 0) through end of study (Day 35) or 30 days after last dose of study drug (whichever is longer) ]
  • Occurrence of treatment-emergent potentially clinically significant (PCS) values for routine clinical laboratory tests. [ Time Frame: Day 0 (baseline), Day 1 (24 hours), Day 7, Day 14, and Day 35 (end of study) ]
  • Occurrence of treatment-emergent PCS vital sign values. [ Time Frame: Day 0 (baseline), Day 1 (24 hours), Day 7, Day 14, and Day 35 (end of study) ]
  • Change from baseline to highest hemoglobin. [ Time Frame: Anytime between baseline (Day 0) and end of study or time of intervention ]
  • Change from baseline to highest ferritin. [ Time Frame: Anytime between baseline (Day 0) and end of study or time of intervention ]
  • Change from baseline to highest TSAT. [ Time Frame: Anytime between baseline (Day 0) and end of study or time of intervention ]


Original Secondary Outcome: Same as current

Information By: Luitpold Pharmaceuticals

Dates:
Date Received: October 4, 2010
Date Started: August 2010
Date Completion:
Last Updated: July 1, 2013
Last Verified: July 2013