Secondary Hyperparathyroidism Clinical Trial
Official title:
Prospective, Open-label, Multicenter Effectiveness and Safety Observational Study of Zemplar in Patients With Stage 5 Chronic Kidney Disease and Hyperparathyroidism on Hemodialysis in the Russian Federation
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at
thirteen sites in Russia. Study drug will be administered per local prescribing guidelines.
Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening
visit. All participants 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 participants 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.
The selected population is representative in relation to those who will take Zemplar in
routine practice. Participants with contraindications to Zemplar therapy (as per the local
label) will not be included in the study.
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Time Perspective: Prospective
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