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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hyperphosphatemia

Intervention / Treatment
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* Drug: Lanthanum carbonate (BAY77-1931)
* Drug: Calcium carbonate


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>750-2250mg/day, tid (three times a day), 8 weeks | Drug: Lanthanum carbonate (BAY77-1931)<br> <br> |
| Active Comparator: Arm 2<br>1500-4500mg/day, tid, 8 weeks | Drug: Calcium carbonate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis