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| Name | Class |
|---|---|
| Jeil-Kirin Pharmaceutical Inc. | INDUSTRY |
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This study is designed in order to investigate the effect of cinacalcet in combination with routine conventional medical management for treatment of secondary hyperparathyroidism (SHPT) and Ca, P control. This study will compare the efficacy of a cinacalcet-based regimen with unrestricted conventional care (vitamin D and phosphate binders) for achieving the stringent National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) targets for dialysis patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinacalcet | Experimental | stepwise dose of cinacalcet + regular medical medication including vit D |
|
| Control | Active Comparator | conventional treatment for secondary HPT including vit D and phosphate binder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cinacalcet | Drug | cinacalcet 25mg qd or 50 mg qd |
| |
| control |
| Measure | Description | Time Frame |
|---|---|---|
| > 30% reduction from baseline of intact parathyroid hormone (iPTH) | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of treatment goal of intact parathyroid hormone (iPTH) (150~300 pg/ml) | 20 weeks | |
| Achievement of targets for mean Ca x P (<55 mg2/dL2), Ca (<9.5 mg/dL), P (<5.5 mg/dL) | 20 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Korea | 110-744 | South Korea | ||
| Kyungpook National University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23705925 | Derived | Kim HJ, Kim H, Shin N, Na KY, Kim YL, Kim D, Chang JH, Song YR, Hwang YH, Kim YS, Ahn C, Lee J, Oh KH; Representing the Cinacalcet stUdy for Peritoneal Dialysis Patients In Double Arm on the Lowing Effect Of iPTH Level (CUPID) Study Group. Cinacalcet lowering of serum fibroblast growth factor-23 concentration may be independent from serum Ca, P, PTH and dose of active vitamin D in peritoneal dialysis patients: a randomized controlled study. BMC Nephrol. 2013 May 25;14:112. doi: 10.1186/1471-2369-14-112. |
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| Drug |
vit D + P binder |
|
| Achieving targets for intact PTH (150-300 pg/ml) and calcium-phosphorus product (Ca x P) (<55 mg2/dl2) simultaneously |
| 20 weeks |
| Vascular calcification score | Abdominal aortic calcification score (AAC, 0-24) will be measured at baseline and at 20 weeks according to Kauppila et al (Atherosclerosis 2004) | 20 weeks |
| Normalization of serum alkaline phosphatase | Serum alkaline phosphatase measured at baseline and 20 weeks | 20 weeks |
| Serum FGF-23 | Elevated serum levels of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients. Therefore, we added analysis of change in FGF23 levels between two treatments to explore the cinacalcet effect in lowering FGF23. | baseline and 20th week |
| Daegu |
| South Korea |
| Gil Hospital | Incheon | South Korea |
| Hallym University Sacred Hospital | Pyungchon | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Eulji University | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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