Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
paricalcitol · 14 trials · 12 indications
The number of participants who achieved (Yes) or did not achieve (No) two consecutive decreases of greater than or equal to 30% from baseline in intact parathyroid hormone (iPTH) values
Glucose AUC during a 2-hour oral glucose tolerance test
The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium \> 11.5 mg/dL or at least 2 consecutive adjusted calcium \>= 11.0 mg/dL during the 52 weeks of the study.
The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus \>= 7.0 mg/dL during the 52 weeks of the study.
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). |
| Group 2 | ACTIVE_COMPARATOR | Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg) |
| A | PLACEBO_COMPARATOR | - |
| B | PLACEBO_COMPARATOR | - |
| Paricalcitol | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Maxacalcitol | ACTIVE_COMPARATOR | 5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis |
| Paricalcitol followed by placebo | ACTIVE_COMPARATOR | Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks. |
| Placebo followed by paricalcitol | ACTIVE_COMPARATOR | Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks. |
| Paricalcitol 2 µg ± 1 µg | EXPERIMENTAL | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| Paricalcitol 2 µg ± 2 µg | EXPERIMENTAL | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| Paricalcitol 4 µg ± 1 µg | EXPERIMENTAL | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| Paricalcitol 4 µg ± 2 µg | EXPERIMENTAL | Study drug was administered 3 times per week (no more frequently than every other day) intravenously immediately before the completion of hemodialysis. The initial dosage was administered for 2 weeks, with subsequent dosage adjustment based on the subject's iPTH, calcium (adjusted), and phosphorus levels every 2 weeks. Total duration of treatment was 48 weeks in this study, combined with 12 weeks in the previous study, M10-309 (NCT00667576), for a total of 52 weeks of treatment. |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| Paricalcitol IV in combination with Gemcitabine IV | EXPERIMENTAL | Patients receive gemcitabine hydrochloride IV over 80 minutes on days 1, 8, and 15 and paricalcitol IV over 15 minutes on days 7 and 14 in course 1. Beginning in course 2, patients receive paricalcitol IV over 15 minutes on days 1, 8, and 15 and gemcitabine hydrochloride IV over 80 minutes on days 2, 9, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| paricalcitol | DRUG | Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details. |
| paricalcitol capsule | DRUG | - |
| paricalcitol capsules | DRUG | baseline iPTH/60 |
| placebo | OTHER | 1-month Placebo Treatment |
| maxacalcitol | DRUG | Intravenous administration 3 times a week immediately before completion of dialysis |
| paricalcitol injection (Zemplar) | DRUG | - |
| Effects on calcium regulation | BEHAVIORAL | - |
| Administration of elemental Ca during hypocalcemic ICU pts. | BEHAVIORAL | - |
| gemcitabine hydrochloride | DRUG | Given IV |
Inclusion Criteria: 1. Subject is a Chinese male or female greater than or equal to 20 years old. 2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemod...
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