Status:
COMPLETED
Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Patients Receiving Hemodialysis
Lead Sponsor:
Abbott
Collaborating Sponsors:
Abbott Japan Co.,Ltd
Conditions:
Chronic Kidney Disease on Hemodialysis
Secondary Hyperparathyroidism
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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 hyperparat...
Detailed Description
This multicenter, randomized, open-label trial consisted of 4 dose-adjustment regimens for paricalcitol injection (initial doses and dose adjustment ranges were 2 ± 1 µg, 2 ± 2 µg, 4 ± 1 µg, and 4 ± 2...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00667576
Start Date
April 1 2008
End Date
March 1 2009
Last Update
January 20 2012
Active Locations (12)
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1
Tokyo, Metropolis, Japan
2
Aichi, Prefecture, Japan
3
Chiba, Prefecture, Japan
4
Fukuoka, Prefecture, Japan