Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CTAP101 30 μg · 2 trials · 3 indications
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...
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CTAP101 30 μg is an investigational small molecule developed by Opko Health Inc. (ticker OPK) for chronic kidney disease. It is being studied in patients with stage 3 or 4 chronic kidney disease who also have vitamin D insufficiency and secondary hyperparathyroidism. It is a 30 microgram dose formulation.
CTAP101 30 μg is being studied to treat secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The Phase 3 trials enrolled patients 18 years and older of all sexes in the United States. It is investigational and has not been approved.
CTAP101 30 μg is developed by Opko Health Inc., which trades under the ticker OPK. The company sponsored the Phase 3 clinical program evaluating the drug in chronic kidney disease patients with secondary hyperparathyroidism and vitamin D insufficiency.
CTAP101 30 μg has completed Phase 3 clinical development. Two Phase 3 trials, both placebo-controlled, randomized, and double-blind, have been completed. The drug is investigational and is not approved for commercial use.
CTAP101 30 μg was evaluated in two completed Phase 3 trials: NCT01704079, which enrolled 216 patients, and NCT01651000, which enrolled 213 patients. Both studied the drug in stage 3 or 4 chronic kidney disease with vitamin D insufficiency and secondary hyperparathyroidism, and together enrolled 429 participants.