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

Phase 3

Completed

• Conditions: Hyperphosphatemia
• Interventions: Drug: Lanthanum carbonate (BAY77-1931); Drug: Calcium carbonate

• Registration Number: NCT01514851
• Lead Sponsor: Bayer

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 Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-23
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-07
• Last Update Posted: 2012-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 259

Inclusion Criteria

• Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.
• Out-patient
• Undergoing hemodialysis three times per week for at least previous 3 consecutive months

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Exclusion Criteria

• Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
• Corrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after
• Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period
• Pregnant woman, or lactating mother
• Significant gastrointestinal disorders including known acute peptic ulcer
• Liver dysfunction
• History of cardiovascular or cerebrovascular diseases
• Requiring treatment for hypothyroidism

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Lanthanum carbonate (BAY77-1931)	750-2250mg/day, tid (three times a day), 8 weeks
Arm 2	Calcium carbonate	1500-4500mg/day, tid, 8 weeks

Primary Outcome Measures

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

Secondary Outcome Measures

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