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