Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Maxacalcitol · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Paricalcitol | EXPERIMENTAL | 2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis |
| 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 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 |
|---|---|---|
| paricalcitol | DRUG | Intravenous administration 3 times a week immediately before completion of dialysis |
| maxacalcitol | DRUG | Intravenous administration 3 times a week immediately before completion of dialysis |
Inclusion Criteria: * Chronic kidney disease (CKD) patients with iPTH \>=300 pg/mL, adjusted calcium \>=8.4 to \<10.2 mg/dL, and phosphorus \<=6.5 mg/dL * Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodial...
Maxacalcitol is being studied for secondary hyperparathyroidism in people with chronic kidney disease who are on hemodialysis. It is an investigational small molecule developed by Abbott Laboratories, and it has been evaluated in Phase 2 clinical research in Japan.
Maxacalcitol is developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker ABT. The company has sponsored Phase 2 clinical research of the drug in Japan for secondary hyperparathyroidism in chronic kidney disease patients receiving hemodialysis.
Maxacalcitol is in Phase 2 development. It is investigational and has not been approved by the FDA. The clinical work completed to date consists of Phase 2 studies conducted in Japan in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.
Maxacalcitol has been studied in completed Phase 2 trials. NCT00990704 compared paricalcitol with maxacalcitol in chronic kidney disease patients with secondary hyperparathyroidism, enrolling 47 participants in Japan. NCT00667576 was a dose-response study of paricalcitol injection in chronic kidney disease patients receiving hemodialysis, enrolling 153 participants in Japan.
No. Maxacalcitol and paricalcitol are separate drugs, although both were evaluated in the same Phase 2 clinical program in Japan. NCT00990704 directly compared paricalcitol with maxacalcitol in chronic kidney disease patients with secondary hyperparathyroidism, and NCT00667576 studied paricalcitol injection in hemodialysis patients.
The Phase 2 program for Maxacalcitol has enrolled 153 participants in total. The studies were randomized and controlled, conducted in Japan, and included adults aged 20 years and older with chronic kidney disease on hemodialysis and secondary hyperparathyroidism. All trials in the program are completed.