Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis (CAPITOL)

• Evaluate changes in ionized Parathyroid Hormone (iPTH) from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Evaluate the proportion of patients with ionized Parathyroid Hormone (iPTH) within National Kidney Foundation Disease Outcomes Quality Initiative (K/DOQI) target at baseline and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Evaluate the proportion of patients with/without elevated serum-Phosphorus(s-P) level at baseline and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  
• Evaluate the proportion of patients with/without elevated serum-Calcium (s-Ca) level at baseline and 6 month [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  

• Evaluation of the mean change in proteinuria at 6 months compared to baseline in those patients with baseline proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Evaluation of the proportion of subjects with a reduction of proteinuria of at least 15% at 6 months compared to baseline in those patients with baseline proteinuria [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Evaluation of the change in patient quality of life (QoL) from Kidney Disease Quality of Life-Short Form (KDQOL-SF) at enrollment and at completion of the study or early termination [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Evaluation of total direct costs of care associated with Secondary Hyperparathyroidism using Work Productivity And Activity Impairment Questionnaire: General Health (WPAI:GH) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Evaluation of total indirect costs of care associated with Secondary Hyperparathyroidism using Work Productivity And Activity Impairment Questionnaire: General Health (WPAI:GH) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  
• Evaluation of changes in concomitant medications and doses [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  

This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed in accordance with the terms of the marketing authorization for patients with Chronic Kidney Disease (CKD) Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care. A retrospective chart review of patient laboratory and medication history will provide historical data to determine drivers for initiation of paricalcitol therapy.

The primary goal of this PMOS is to further characterize the prescribing habits and patient management practices of physicians prescribing paricalcitol capsules and to assess the metabolic safety and effectiveness of paricalcitol capsules for the treatment of SHPT in stage 3-5 CKD patients not yet on dialysis under conditions of usual clinical care. Focus will be to examine the practice of dose titration in early stages of CKD, understand real-world management of intact PTH levels, understand real-world incidence and management of abnormalities in serum calcium and phosphate, and to examine patient bone and mineral profiles and medical history to understand drivers for paricalcitol capsules use.

Patients prescribed Zemplar® (paricalcitol capsules) therapy for the first time will be asked to participate in the study. Enrolled patients will be followed for 6 months.