A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

Exclusion Criteria

• •Subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug
• •Subject has had active peritonitis within 1 month prior to screening phase.
• •Subject has had more than one episode of peritonitis within 4 months prior to screening phase.
• •Subject has received a partial parathyroidectomy within 1 year prior to screening phase.
• •Subject has had acute renal failure within 3 months of screening phase.
• •Subject has chronic gastrointestinal disease.
• •Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study.
• •Subject has a current malignancy or clinically significant liver disease.
• •Subject has a history of drug or alcohol abuse within 6 months prior to screening phase.
• •Subject has evidence of poor compliance with diet, medication, or PD.
• •Subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase.
• •Subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
• •For any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules.
• •Subject is known to be HIV positive.