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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02282813 | Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002 | PHASE3 | COMPLETED | 298 | — | — | Apr 1, 2013 | May 1, 2015 | Sep 29, 2016 | - | — |
| NCT00888069 | Pharmacokinetics and Safety Pilot Study of Single-Dose Oral and Intravenous CTAP101 in Stage 3 and 4 Chronic Kidney Disease Subjects | PHASE1 | COMPLETED | 28 | — | — | May 1, 2009 | Dec 1, 2009 | Sep 30, 2014 | 12 | United States |
Number of subjects in the intent to treat population with a mean reduction in plasma intact parathyroid hormone (iPTH) of \>/= 30% from pretreatment baseline values at end of treatment (EOT), classified as responders
| Arm | Type | Description |
|---|---|---|
| CTAP101 Capsules alone | EXPERIMENTAL | CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks |
| CTAP101 Capsules +calcitriol | EXPERIMENTAL | CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks |
| CTAP101 Capsules +doxercalciferol | EXPERIMENTAL | CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks |
| CTAP101 Capsules +paricalcitol | EXPERIMENTAL | CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks |
| 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 |
|---|---|---|
| CTAP101 Capsules | DRUG | At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily |
| Calcitriol | DRUG | At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily |
| Doxercalciferol | DRUG | At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily |
| Paricalcitol | DRUG | At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily |
| CTAP101 Injection | DRUG | single IV injection |
Inclusion Criteria: * Completed either of the phase 3 double-blind, placebo-controlled studies, CTAP101-CL-3001 or CTAP101-CL-3002 * Taking no more than 1000 mg/day of elemental Ca and willing/able to remain on this dose for the duration of the study * Taking no more than 1600 IU/dose vitamin D (er...