Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Hemodialysis
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary hyperparathyroidism, Paricalcitol, Hemodialysis, Maxacalcitol
Eligibility Criteria
Inclusion Criteria:
- Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
- On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.
Exclusion Criteria:
- Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
- Patients who have received a parathyroidectomy or ethanol infusion within the prior year
- Patients taking drugs that affect iPTH, calcium or bone metabolism
- Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
- Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.
Sites / Locations
- Site Reference ID/Investigator# 53485
- Site Reference ID/Investigator# 51571
- Site Reference ID/Investigator# 52963
- Site Reference ID/Investigator# 52966
- Site Reference ID/Investigator# 51578
- Site Reference ID/Investigator# 52965
- Site Reference ID/Investigator# 53782
- Site Reference ID/Investigator# 57483
- Site Reference ID/Investigator# 57487
- Site Reference ID/Investigator# 53484
- Site Reference ID/Investigator# 54385
- Site Reference ID/Investigator# 51581
- Site Reference ID/Investigator# 59164
- Site Reference ID/Investigator# 51574
- Site Reference ID/Investigator# 51575
- Site Reference ID/Investigator# 52751
- Site Reference ID/Investigator# 62025
- Site Reference ID/Investigator# 54384
- Site Reference ID/Investigator# 52745
- Site Reference ID/Investigator# 51569
- Site Reference ID/Investigator# 52964
- Site Reference ID/Investigator# 53483
- Site Reference ID/Investigator# 51582
- Site Reference ID/Investigator# 54388
- Site Reference ID/Investigator# 51576
- Site Reference ID/Investigator# 51577
- Site Reference ID/Investigator# 51580
- Site Reference ID/Investigator# 52747
- Site Reference ID/Investigator# 52748
- Site Reference ID/Investigator# 52750
- Site Reference ID/Investigator# 51570
- Site Reference ID/Investigator# 54387
- Site Reference ID/Investigator# 52746
- Site Reference ID/Investigator# 51579
- Site Reference ID/Investigator# 62024
- Site Reference ID/Investigator# 51572
- Site Reference ID/Investigator# 52752
- Site Reference ID/Investigator# 53482
- Site Reference ID/Investigator# 59162
- Site Reference ID/Investigator# 59966
- Site Reference ID/Investigator# 53783
- Site Reference ID/Investigator# 54383
- Site Reference ID/Investigator# 52749
- Site Reference ID/Investigator# 52962
- Site Reference ID/Investigator# 59163
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Paricalcitol
Maxacalcitol
Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.