Secondary Hyperparathyroidism Clinical Trial
Official title:
Late Phase 2 Study of Paricalcitol Injection: Dose-response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose)
Verified date | January 2012 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 153 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott | Abbott Japan Co.,Ltd |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects With = 50% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Serum Level | Baseline to Week 13 (Final Visit) | No | |
Secondary | Mean Change From Baseline in Intact Parathyroid Hormone (iPTH) Level | Baseline to Week 13 (Final Visit) | No | |
Secondary | Percentage of Subjects With Intact Parathyroid Hormone (iPTH) = 180 Picograms/Milliliter (pg/mL) | Baseline to Week 13 (Final Visit) | No | |
Secondary | Percentage of Subjects With 2 or More Decreases of = 50% From Baseline in Intact Parathyroid Hormone (iPTH) Level | Through Week 13 | No | |
Secondary | Duration of 2 Consecutive Decreases of = 50% From Baseline in Intact Parathyroid Hormone (iPTH) Values | Through Week 13 | No | |
Secondary | Duration of 2 Consecutive Intact Parathyroid Hormone (iPTH) Values = 180 pg/mL | Through Week 13 | No |
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