Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Abbott
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Under care of physician at least 2 months (for CKD)
Not on active Vitamin D therapy for at least 4 weeks prior
If female:
* Not of childbearing potential, OR
* Practicing birth control
* Not breastfeeding
If taking phosphate binders, on a stable regimen at least 4 weeks prior
For entry into Pretreatment Phase:
* iPTH at least 120 pg/mL
* GFR of 15-60 mL/min and no dialysis expected for at least 6 months
For entry into Treatment Phase:
* Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL
* 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL
* 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL
You may not be if
History of allergic reaction or sensitivity to similar drugs
Acute Renal Failure within 12 weeks of study
Chronic gastrointestinal disease
Spot urine result demonstrating a urine-calcium-to-urine creatinine ratio of greater than 0.2, or a history of renal stones
Taken aluminum-containing phosphate binders within last 12 weeks, or requires such medication for more than 3 weeks during study
Current malignancy, or clinically significant liver disease
Active granulomatous disease (TB, sarcoidosis, etc.)
History of drug or alcohol abuse within 6 mos. prior
Evidence of poor compliance with diet or medication
Received any investigational drug or participated in any device trial within 30 days prior
Taking maintenance calcitonin, bisphosphonates, or drugs that may affect calcium or bone metabolism (other than females on stable estrogen and/or progestin therapy)
On glucocorticoids for a period of more than 14 days within the last 6 months
