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

• 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. Planned therapy will be six months. Patients with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed during the period of the study.

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.

Hemodialysis centers

Inclusion Criteria:

1. Age 18-65 years
2. Chronic Kidney Disease stage 5 receiving hemodialysis
3. Authorization (Consent) for Use/Disclosure of Data signed by the patient
4. Planned prescription of Zemplar treatment due to fair clinical need and irrespectively of the participation in the current program according to the local label within 2 weeks after screening into the program
5. Screening intact Parathyroid Hormone level (measured not earlier than 1 month before first dose of Zemplar) between 300 and 900 pg/ml

Exclusion Criteria:

1. Contraindications to Zemplar as indicated in approved label, including but not limited to hypersensitivity, hypervitaminosis D (serum D3 level above 32 ng/ml), concomitant use of vitamin D or phosphates, lactation period, pregnancy
2. Any experimental drug within the period of 30 days before the inclusion into the program
3. Screening Ca x P > 65 mg2/dL2
4. Screening normalized serum total calcium > 10.2 mg/dL
5. Necessity for calcitonin maintenance oral or intravenous glucocorticoids, or other drugs that could have affected calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy