Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
* 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
