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To evaluate the efficacy and safety of treatment with SK-1403 for 24 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SK-1403 | Experimental | Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. |
|
| Placebo | Placebo Comparator | Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SK-1403 | Drug | Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants who achieved a mean serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL from 22 to 24 week. | Assessed by laboratory test value | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point. | Assessed by laboratory test value | 24 weeks |
| Measured values and Changes from baseline in serum PTH |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site (there may be other sites in this country) | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37696667 | Derived | Shigematsu T, Koiwa F, Isaka Y, Fukagawa M, Hagita K, Watanabe YS, Honda D, Akizawa T. Efficacy and Safety of Upacicalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: A Randomized Placebo-Controlled Trial. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1300-1309. doi: 10.2215/CJN.0000000000000253. Epub 2023 Sep 11. |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| Placebo | Drug | Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment. |
|
Assessed by laboratory test value; unit of measure (pg/mL)
| 24 weeks |
| Measured values and Changes from baseline in Ca | Assessed by laboratory test value; unit of measure (mg/dL) | 24 weeks |
| Measured values and Changes from baseline in ionized Ca | Assessed by laboratory test value; unit of measure (mEq/dL) | 24 weeks |
| Measured values and Changes from baseline in P | Assessed by laboratory test value; unit of measure (mg/dL) | 24 weeks |
| Measured values and Changes from baseline in serum Ca x P product | Assessed by laboratory test value | 24 weeks |