Status:
COMPLETED
Paricalcitol Compared to Maxacalcitol in Chronic Kidney Disease Patients With Secondary Hyperparathyroidism
Lead Sponsor:
Abbott
Conditions:
Secondary Hyperparathyroidism
Hemodialysis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyp...
Eligibility Criteria
Inclusion
- Chronic kidney disease (CKD) patients with iPTH \>=300 pg/mL, adjusted calcium \>=8.4 to \<10.2 mg/dL, and phosphorus \<=6.5 mg/dL
- Patients receiving dialysis 3 times weekly for at least 3 months before informed consent was obtained and scheduled to receive the same hemodialysis during the study period
- Patients using dialysate with constant concentration of calcium for 4 weeks before informed consent was obtained and receiving phosphate binder with constant dose regimen for 2 weeks before informed consent was obtained
Exclusion
- Patients taking drugs that affect iPTH, calcium, or bone metabolism
- Patients with a history of allergic reaction or significant sensitivity to vitamin D
- Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained
- Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease
- Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:
- Acute coronary syndrome (myocardial infarction or unstable angina) or acute cerebral vascular disease (cerebral infarction or cerebral hemorrhage)
- Coronary arterial revascularization (such as coronary artery bypass grafting, percutaneous transluminal coronary angioplasty)
- Cerebral arterial revascularization (such as cerebral aneurysm clipping, cerebral aneurysm embolization, carotid artery endarterectomy)
- Arteriosclerosis obliterans with rest pain (Fontaine classification III or more severe)
- Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic \>= 180 mmHg and diastolic \>= 110 mmHg)
- Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin \>=8% for 3 months before informed consent was obtained)
- Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained
- Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers
- Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained
- Patients who have taken paricalcitol in the past
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00990704
Start Date
October 1 2009
End Date
May 1 2010
Last Update
July 11 2011
Active Locations (14)
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1
Site Ref # / Investigator 53794
Anjo, Japan
2
Site Ref # / Investigator 53787
Chiba, Japan
3
Site Ref # / Investigator 53786
Kumagaya, Japan
4
Site Ref # / Investigator 53792
Matsumoto, Japan