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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
259
Unnamed facility
Toyohashi, Aichi-ken, Japan
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Yatomi, Aichi-ken, Japan
Unnamed facility
Asahi, Chiba, Japan
Unnamed facility
Chiba, Chiba, Japan
Unnamed facility
Kashiwa, Chiba, Japan
Unnamed facility
Matsudo, Chiba, Japan
Unnamed facility
Narita, Chiba, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Kurume, Fukuoka, Japan
Unnamed facility
Isesaki, Gunma, Japan
...and 21 more locations