Clinical Trial: Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate

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

Official Title: Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis

Brief Summary: To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome:

  • Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period [ Time Frame: baseline to week 8 ]
  • Presence/absence of incidence of hypercalcemia up to 8 weeks [ Time Frame: up to 8 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants achieving target PSPL and time to achievement [ Time Frame: up to 8 weeks ]
  • Serum calcium x phosphate product at the end of the double-blind treatment period [ Time Frame: Week 8 ]
  • Serum intact-PTH (Parathyroid) levels [ Time Frame: Week 8 ]
  • Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period [ Time Frame: Week 8 ]
  • Number of participants achieving the target serum calcium levels [ Time Frame: Week 8 ]
  • Safety variables will be summarized using descriptive statistics based on adverse events collection [ Time Frame: 8 weeks ]


Original Secondary Outcome: Same as current

Information By: Bayer

Dates:
Date Received: January 18, 2012
Date Started: January 2006
Date Completion:
Last Updated: June 7, 2012
Last Verified: June 2012