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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosrenol (Lanthanum Carbonate, BAY77-1931) | Drug | Daily dose: 750-2250mg 3 times a dayfor 8 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in serum phosphate concentrations | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of target serum phosphate level (2.7 to 4.6 mg/dL) | Week 0, Week 2, Week 4, Week 6, Week 8 | |
| Change in serum Calcium x Phosphor product | Week 0, Week 2, Week 4, Week 6, 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 |
|---|---|---|---|---|---|---|
| Anjo | Aichi-ken | 446-8602 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. | |
| 25079863 | Derived | Takahara Y, Matsuda Y, Takahashi S, Shigematsu T; Lanthanum Carbonate Study Group. Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial. Clin Nephrol. 2014 Sep;82(3):181-90. doi: 10.5414/cn108269. |
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| Placebo |
| Drug |
daily dose: 3 tablets TID for 8 weeks. |
|
| Serum intact PTH level |
| Week 0, Week 2, Week 4, Week 6, Week 8 |
| Phosphate excretion in urine | Week 0, Week 4, Week 8 |
| Nagoya |
| Aichi-ken |
| 455-8530 |
| Japan |
| Nagoya | Aichi-ken | 457-8510 | Japan |
| Nagoya | Aichi-ken | 460-0001 | Japan |
| Nagoya | Aichi-ken | 466-8650 | Japan |
| Seto | Aichi-ken | 489-8642 | Japan |
| Toyohashi | Aichi-ken | 441-8021 | Japan |
| Yatomi | Aichi-ken | 498-8502 | Japan |
| Kamogawa | Chiba | 296-0041 | Japan |
| Kisarazu | Chiba | 292-8535 | Japan |
| Fukuoka | Fukuoka | 810-8563 | Japan |
| Fukuoka | Fukuoka | 814-0180 | Japan |
| Kitakyushu | Fukuoka | 802-8555 | Japan |
| Kitakyushu | Fukuoka | 805-0050 | Japan |
| Koga | Fukuoka | 811-3195 | Japan |
| Sapporo | Hokkaido | 063-0005 | Japan |
| Amagasaki | Hyōgo | 660-0828 | Japan |
| Fujisawa | Kanagawa | 251-8550 | Japan |
| Kamakura | Kanagawa | 247-8533 | Japan |
| Yokohama | Kanagawa | 231-8682 | Japan |
| Yokohama | Kanagawa | 234-8503 | Japan |
| Kyoto | Kyoto | 612-8555 | Japan |
| Beppu | Oita Prefecture | 874-0011 | Japan |
| Ōita | Oita Prefecture | 870-0263 | Japan |
| Kurashiki | Okayama-ken | 710-8602 | Japan |
| Okayama | Okayama-ken | 700-0013 | Japan |
| Osaka | Osaka | 530-0012 | Japan |
| Osaka | Osaka | 530-8480 | Japan |
| Osaka | Osaka | 534-0021 | Japan |
| Osaka | Osaka | 558-8558 | Japan |
| Sakai | Osaka | 591-8025 | Japan |
| Saga | Saga-ken | 840-0054 | Japan |
| Shizuoka | Shizuoka | 421-0193 | Japan |
| Tokushima | Tokushima | 770-0011 | Japan |
| Koto | Tokyo | 136-0075 | Japan |
| Meguro-ku | Tokyo | 152-8902 | Japan |
| Minato-ku | Tokyo | 105-8471 | Japan |
| Musashino | Tokyo | 180-8610 | Japan |
| Shinagawa | Tokyo | 141-8625 | Japan |
| Wakayama | Wakayama | 641-8510 | Japan |
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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