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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00667576 | Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis | PHASE2 | COMPLETED | 153 | — | — | Apr 1, 2008 | Mar 1, 2009 | Jan 20, 2012 | 12 | Japan |
| Arm | Type | Description |
|---|---|---|
| Paricalcitol 2 µg ± 1 µg | EXPERIMENTAL | Paricalcitol initial dosage 2 micrograms (µg) with incremental adjustment of 1 µg |
| Paricalcitol 2 µg ± 2 µg | EXPERIMENTAL | Paricalcitol initial dosage 2 µg with incremental adjustment of 2 µg |
| Paricalcitol 4 µg ± 1 µg | EXPERIMENTAL | Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg |
| Paricalcitol 4 µg ± 2 µg | EXPERIMENTAL | Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg |
| Maxacalcitol 5 or 10 µg ± 2.5 µg | OTHER | Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg |
| Name | Type | Description |
|---|---|---|
| Maxacalcitol | DRUG | 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 12 weeks. |
| Paricalcitol | DRUG | 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 12 weeks. |
Inclusion Criteria: * Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period. * Using dialysate with constant concentration of calcium for 4...