Long-Term Therapy Outcomes When Treating Chronic Kidney Disease (CKD) Patients With Paricalcitol in German and Austrian Clinical Practice

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-Term Therapy Outcomes When Treating CKD-patients With Paricalcitol in German Clinical Practice (TOP Study)

Conditions
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Kidney Insufficiency, Secondary Hyperparathyroidism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria are based on the Summary of Product Characteristics for paricalcitol injection and capsules: Prevention and therapy of secondary hyperparathyroidism in the presence of chronic kidney disease Patients not treated with paricalcitol for at least 6 months prior to inclusion in this study Exclusion Criteria: The contraindications listed in the Summary of Product Characteristics for paricalcitol injection and capsules apply An additional exclusion criterion is a parathyroid hormone- value of > 1000 pg/mL (which may be a sign of tertiary hyperparathyroidism) and existing treatment with paricalcitol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paricalcitol<br>Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL). | Up to 12 Months | 
| Time to Achieve Target Range of Intact Parathyroid Hormone (iPTH) Levels Within the Target Range After 12 Months | Participants achieved Intact Parathyroid Hormone (iPTH) levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines (Chronic Kidney Disease (CKD), stage 3: 35 to 70 pg/mL; CKD stage 4: 70 to 110 pg/mL; CKD stage 5: 150 to 300 pg/mL). | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Hypercalcemia | Hypercalcemia was defined as having a serum calcium level greater than 11.2 mg/dL (2.79 mmol/L), in one measurement. Serum calcium was measured at every study visit. | Months 0, 3, 6, 9, and 12 | 
| Number of Participants With Hyperphosphatemia | Hyperphosphatemia was defined as having a serum phosphate level greater than 6.5 mg/dL (2.10 mmol/L), in one measurement. Serum phosphate was measured at every study visit. | Months 0, 3, 6, 9, and 12 | 
| Number of Participants With Elevated Calcium-Phosphorus Product | Elevated Calcium-Phosphorus Product was defined as having a calcium-phosphate product level greater than 65 mg^2/dL^2, in one measurement. Serum calcium-phosphorus product was measured at every study visit. | Months 0, 3, 6, 9, and 12 | 
| Mean Duration of Hospitalization by Visit |  | Months 0, 3, 6, 9, and 11 | 
| Mean Duration of Disability by Visit |  | Months 0, 3, 6, 9, and 11 | 
| Mean Intact Parathormone (iPTH) Levels by Visit |  | Months 0, 3, 6, 9, and 12 | 
| Mean Calcium-Phosphate Product Levels by Visit |  | Months 0, 3, 6, 9, and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Observational study, Paricalcitol, Treatment of Hyperparathyroidism, Chronic kidney disease stage 3, 4 and 5 (CKD stage 3, 4 and 5), Chronic Kidney Disease, Zemplar, sHPT, Secondary