Safety and Efficacy of Zemplar Capsule in Reducing Serum iPTH Levels in Chronic Kidney Disease Subjects (Three Times Weekly)

Exclusion Criteria

• •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
• •HIV positive