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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 750-2250mg/day, tid (three times a day), 8 weeks |
|
| Arm 2 | Active Comparator | 1500-4500mg/day, tid, 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate (BAY77-1931) | Drug |
| ||
| Calcium carbonate |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toyohashi | Aichi-ken | 441-8023 | Japan | |||
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|
| 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 |
| Yatomi |
| Aichi-ken |
| 498-0006 |
| Japan |
| Asahi | Chiba | 289-2511 | Japan |
| Chiba | Chiba | 261-0011 | Japan |
| Kashiwa | Chiba | 277-0084 | Japan |
| Matsudo | Chiba | 271-0077 | Japan |
| Narita | Chiba | 286-0041 | Japan |
| Kurume | Fukuoka | 830-8522 | Japan |
| Kurume | Fukuoka | 830-8543 | Japan |
| Isesaki | Gunma | 379-2211 | Japan |
| Hiroshima | Hiroshima | 730-0811 | Japan |
| Kobe | Hyōgo | 658-0084 | Japan |
| Mito | Ibaraki | 310-0844 | Japan |
| Tsuchiura | Ibaraki | 300-0053 | Japan |
| Takamatsu | Kagawa-ken | 761-8024 | Japan |
| Kochi | Kochi | 780-0066 | Japan |
| Ōsaki | Miyagi | 989-6117 | Japan |
| Sendai | Miyagi | 981-0912 | Japan |
| Okayama | Okayama-ken | 701-0202 | Japan |
| Suita | Osaka | 564-0053 | Japan |
| Saitama | Saitama | 330-0854 | Japan |
| Saitama | Saitama | 330-0856 | Japan |
| Saitama | Saitama | 337-0043 | Japan |
| Fuji | Shizuoka | 417-0056 | Japan |
| Hamamatsu | Shizuoka | 430-0903 | Japan |
| Tokushima | Tokushima | 770-0011 | Japan |
| Arakawa-ku | Tokyo | 116-0003 | Japan |
| Kodaira | Tokyo | 187-0001 | Japan |
| Nerima-ku | Tokyo | 176-0023 | Japan |
| Shibuya-ku | Tokyo | 151-0053 | Japan |
| Shinjyuku-ku | Tokyo | 160-0023 | Japan |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |
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