Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation

• The proportion of patients who have reached a target level of iPTH (150-300 pg/mL) at least once during the program period [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  

• Proportion of patients who have reached the Kidney Disease Improving Global Outcomes target level of iPTH (2 times to 9 times upper limit of normal) at least once during the observation period [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  
• Proportion of patients who have reached the Kidney Disease Improving Global Outcomes target level at each month [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  
• Proportion of patients who have developed elevated Ca x P (> 75 mg2/dL2) at least once during the observation period [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  
• Proportion of patients who have developed elevated Ca x P (> 75 mg2/dL2) at ) at each month [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  
• Proportion of patients who have developed elevated normalized total calcium (> 11.2 mg/dL) at least once during the observation period [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  
• Proportion of patients who have developed elevated normalized total calcium (> 11.2 mg/dL) at each month [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  
• Proportion of patients who have developed hypercalcemia and hyperphosphatemia leading to study termination [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  

Eighty-six eligible patients with secondary hyperparathyroidism will be enrolled at fifteen sites in Russia. Study drug is to be administered intravenously no more than every other day. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All patients who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.

Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).

Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of patients with the level of intact Parathyroid Hormone 150 - 300 pg/ml was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.

Selected population is representative in relation to the patients who will take Zemplar in routine practice. Patient with contraindications to Zemplar therapy (as per the local label) will not be included into the study.