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This study will compare CTAP201 with Doxercalciferol in patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT), undergoing regular hemodialysis, at different dose strengths. This study will also investigate the levels of CTAP201 in the body over time and determine the safety of CTAP201.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTAP201 Injection at dose a | Experimental | CTAP201 at dose a |
|
| CTAP201 Injection | Experimental | CTAP201 at dose b or dose c |
|
| Doxercalciferol at dose a | Active Comparator | Active at dose a |
|
| Doxercalciferol | Active Comparator | Active at dose b or dose c |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTAP201 Injection | Drug | Comparison of different dose strengths of CTAP201 after single dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood levels of CTAP201 and doxercalciferol | Day 1 and Day 15 of each dose level | |
| Safety of a single dose of CTAP201 Injection | Throughout the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Melnick, MD | OPKO Renal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pivotal Reseach Centers | Peoria | Arizona | 85381 | United States | ||
| Western New England Renal and Transplant Associates |
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| Doxercalciferol | Drug | Comparison of different dose strengths of doxercalciferol after single dose. |
|
|
| Springfield |
| Massachusetts |
| 01107 |
| United States |
| University of Cincinnati | Cincinnati | Ohio | 45206 | United States |
| Northeast Clinical Research | Allentown | Pennsylvania | 18103-6379 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Southwest Houston Research Ltd. | Houston | Texas | 77099 | United States |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| D007676 | Kidney Failure, Chronic |
| D010279 | Parathyroid Diseases |
| D051437 | Renal Insufficiency |
| D006961 | Hyperparathyroidism |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| 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 |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C042533 | 1 alpha-hydroxyergocalciferol |
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