Secondary Hyperparathyroidism Clinical Trial
Official title:
Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)
The purpose of this study is to obtain data on the safety and effectiveness of Zemplar® (paricalcitol) injection and paricalcitol capsules in real-life clinical practice. Participants, who have been treated with paricalcitol in-label in an everyday setting, have been included into this study. A period of 12 months has been chosen in order to also obtain experience on the maintenance dose and treatment optimization with paricalcitol injection and paricalcitol capsules in long-term use.
According to protocol amendment of 16 October 2010 Austria is participating in this study.
Paricalcitol injection (intravenous (IV) therapy) was approved in Germany in December 2004
and in Austria in June 2003 for the prevention and treatment of secondary
hyperparathyroidism in participants needing dialysis. In April 2008 in Germany and in
January 2008 in Austria, paricalcitol capsules (for oral use (p.o.)) were launched for the
prevention and treatment of secondary hyperparathyroidism in individuals with Chronic Kidney
Disease stage 3 - 5 (i.e., predialysis and dialysis), thus enabling early treatment of
participants with chronic kidney disease before they reach the stage of requiring dialysis.
Postmarketing observational studies with a well-planned study design, defined study protocol
and biometrical estimates are necessary for a more profound understanding of the
effectiveness and adverse drug reactions, especially those that are unknown or rare.
Accordingly, the purpose of this study is to obtain data on the safety and effectiveness of
paricalcitol injection and capsules in real-life clinical practice. In this study,
paricalcitol will be prescribed on an on-label basis in an everyday setting. A period of 12
months has been consciously chosen in order to also obtain experience on the maintenance
dose and treatment optimization with paricalcitol injection and paricalcitol capsules in
long-term use.
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Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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