Clinical Trial: Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)
Brief Summary: The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis.
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Change from baseline in serum phosphate levels at the end of the treatment period [ Time Frame: Baseline to Week 8 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement [ Time Frame: Week 8 ]
- Serum calcium level corrected by serum albumin level at the end of the treatment period [ Time Frame: Week 8 ]
- Serum calcium x phosphate product at the end of the treatment period [ Time Frame: Week 8 ]
- Serum intact-PTH (Parathyroid) levels at the end of the treatment period [ 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: March 10, 2016
Last Verified: March 2016
