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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01704079 | Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency | PHASE3 | COMPLETED | 216 | — | — | Nov 1, 2012 | Sep 1, 2014 | Jan 13, 2025 | 1 | United States |
| NCT01651000 | Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency | PHASE3 | COMPLETED | 213 | — | — | Sep 1, 2012 | Jul 1, 2014 | Jan 13, 2025 | 1 | United States |
Number of subjects in the intent to treat population attaining mean decrease in plasma intact Parathyroid Hormone (iPTH) of ≥30% from P\\pre-treatment baseline in the efficacy assessment phase (EAP) referred to as responders
Number of subjects in the intent to treat population attaining a mean decrease in plasma intact parathyroid hormone (iPTH) of ≥30% from pre-treatment baseline in the efficacy assessment phase (EAP), referred to as responders.
| Arm | Type | Description |
|---|---|---|
| CTAP101 30 μg capsules | ACTIVE_COMPARATOR | 1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26. |
| Sugar pill to CTAP101 30 μg | PLACEBO_COMPARATOR | 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. |
| Sugar pill to CTAP101 30 μg capsule | PLACEBO_COMPARATOR | 1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26. |
| Name | Type | Description |
|---|---|---|
| CTAP101 30 μg capsules | DRUG | CTAP101 30 μg capsule taken daily at bedtime |
| Sugar pill to CTAP101 30 μg capsules | OTHER | Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime. |
Inclusion Criteria: 1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine 2. Stage 3 or 4 CKD 3. Plasma iPTH: ≥ 85 pg/mL and \< 500 pg/mL 4. Serum Ca: ≥ 8.4 mg/dL and \< 9.8 mg/dL 5. Serum P: ≥ 2.0 mg/dL and \< 5.0 mg/dL 6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and \< 30 ng/mL. 7. Stable dose of...