Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00792857 | Comparison of I.V. CTAP201 and Doxercalciferol (Hectorol) in Subjects With Chronic Kidney Disease (CKD) and Secondary Hyperparathyroidism (SHPT) | PHASE1 | COMPLETED | 24 | — | — | Nov 1, 2008 | Oct 1, 2009 | Sep 29, 2014 | 6 | United States |
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| CTAP201 Injection | DRUG | Comparison of different dose strengths of CTAP201 after single dose. |
| Doxercalciferol | DRUG | Comparison of different dose strengths of doxercalciferol after single dose. |
Inclusion Criteria: * Body mass index between 18 and 40 * On maintenance hemodialysis three times per week * Visit 1: Serum iPTH value greater than or equal to 200 pg/mL and lower than or equal to 1000 pg/mL * Visit 1: Serum total calcium value greater than 8.4 mg/dL and lower than 10.0 mg/dL * Vis...