Clareo Health | Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie (prior sponsor, Abbott)
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
