Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to investigate the initial dose and dose adjustment range for paricalcitol injection in patients with chronic kidney disease on hemodialysis who have secondary hyperparathyroidism.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborator: Abbott Japan Co.,Ltd
• Treatments: Calcitriol; Ergocalciferols; Maxacalcitol

Criteria

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 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.

• Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL

• Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)

• Phosphorus ≤ 6.5 mg/dL

• Age ≥ 20 years

Exclusion Criteria:

• History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds

• Parathyroidectomy or ethanol infusion within past year

• Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus

• Drug or alcohol abuse within past 6 months

• Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)

• Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)

• Taking aluminum containing products (2 weeks prior to consent)