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This study will investigate how the levels of a single dose of CTAP101 changes in the body over time (pharmacokinetics, PK) and how CTAP101 affects other mineral and hormonal balances (pharmacodynamics, PD) in patients with Stage 3 or 4 chronic kidney disease (CKD) with vitamin D insufficiency and secondary hyperparathyroidism (SHPT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose CTAP101 Capsules | Experimental | CTAP101 Capsules, 450 mcg dose |
|
| High Dose CTAP101 Capsules | Experimental | CTAP101 Capsules, 900 mcg dose |
|
| CTAP101 Injection | Experimental | IV injection, 448 mcg dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTAP101 Capsules | Drug | Single dose oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the PK and bioavailability of CTAP101 in Stage 3 and 4 CKD subjects with vitamin D insufficiency and SHPT | from 3 to 0 hours prior to dosing until 42 days post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of CTAP101 capsules and injection | From signing of ICF (Day -35) through study completion (Day 42 post dosing) | |
| To assess the pharmacodynamics of single dose CTAP101 in Stage 3 and Stage 4 CKD subjects with vitamin D insufficiency and SHPT. |
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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 Research Centers | Peoria | Arizona | 85381 | United States | ||
| Research by Design |
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| CTAP101 Injection | Drug | single IV injection |
|
| From signing of ICF (Day -35) through study completion (Day 42 post dosing) |
| Evergreen Park |
| Illinois |
| 60805 |
| United States |
| Western New England Renal & Transplant Associates | Springfield | Massachusetts | 01107 | United States |
| Twin Cities Clinical Research | Brooklyn Center | Minnesota | 55430 | United States |
| DCI | Cincinnati | Ohio | 45206 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109-1998 | United States |
| Northeast Clinical Research | Allentown | Pennsylvania | 18103 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37404 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Southwest Houston Research Ltd | Houston | Texas | 77099 | United States |
| Purity Dialysis Centers / Nephrology Associates | Delafield | Wisconsin | 53018 | United States |
| Gunderson Clinic Ltd. | La Crosse | Wisconsin | 54601 | 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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