Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years

Study Overview
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Brief Summary
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The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.

Detailed Description
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Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage 5 receiving dialysis. SHPT is an adaptive response to CKD and is characterized by an elevation in parathyroid hormone (PTH) and consecutively high calcium levels. Elevations in calcium levels, phosphate levels, and PTH are correlated with CKD disease progression as well as development or aggravation of cardiovascular impairment. Many CKD patients cannot be treated well with Vitamin D analogues because of effects on calcium. Hypercalcemia is a well - known factor for cardiac disease. No data are available in Austria for a cohort with cardiac disease treated with Zemplar (paricalcitol IV).

Official Title
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Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.

Conditions
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Secondary Hyperparathyroidism, Chronic Kidney Disease Stage V, Cardiac Morbidity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged at least 18 years Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL, Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms: cardiac disorder as cardiac arrhythmias cardiac disorder signs and symptoms cardiac neoplasm cardiac valve disorder heart failures myocardial disorder pericardial disorder Serum phosphate level < 6.5 mg/dL and serum calcium level < 10.5 mg/dL Exclusion Criteria: Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.

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 IV<br>Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range | Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL). | Baseline and Months 3, 6, 12, 18, and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Hypercalcemia | Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit. | Baseline and Months 3, 6, 12, 18, and 24 | 
| Percentage of Participants With Hyperphosphatemia | Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit. | Baseline and Months 3, 6, 12, 18, and 24 | 
| Percentage of Participants With at Least a 30%-Reduction in iPTH Levels | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level. | Baseline and Months 3, 6, 12, 18, and 24 | 
| Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements | The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits. | Baseline to Month 24 | 
| Percentage of Participants With at Least One Concomitant Medication | The percentage of participants with at least one concomitant medication during the course of the study, by the following types: Phosphate binder Epoetin Renin-Angiotensin-Aldosterone System (RAAS) inhibitors Cinacalcet Other | 24 months | 
| Percentage of Participants Experiencing Hospitalization | The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study. | 24 months | 
| Number of Participants With Cardiac Disease Progression | Cardiac disease progression was determined by the Investigator. | Month 3, 6, 12, 18, and 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary Hyperparathyroidism (sHPT), Paricalcitol, Chronic kidney disease stage 5 (CKD stage 5)