Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis

Study Overview
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Brief Summary
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This is the post-marketing study conducted in two countries: Croatia and Serbia. In both countries Zemplar (paricalcitol) is the first injectable form of any Vitamin D Receptor (VDR) activator available for chronic kidney disease patients on hemodialysis. The evaluation of outcomes of VDR activator treatments in clinical practice is a major challenge in the management of this patient population. The aim of this post-marketing observational study is to obtain further data on the outcomes of Zemplar Injection administration during routine clinical use.

Detailed Description
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This study is a non-interventional, observational study in which Zemplar® Injection is prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics (SmPC) with regards to dose, population and indication. The study population consists of participants receiving hemodialysis in whom the diagnosis of secondary hyperparathyroidism has been established, and who are not adequately controlled with the oral VDR activator (calcitriol or alfacalcidol). Participants will be included via consecutive sampling. To be included, participants should have a clinical indication to initiate treatment with Zemplar® Injection due to: (1) a diagnosis of secondary hyperparathyroidism and (2) because they require a change in treatment for secondary hyperparathyroidism (e.g. due to a lack of effectiveness of the previous treatment). Each participant will be observed during his/her Zemplar® Injection treatment regimen for a maximum period of 12 months.

Official Title
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A One-year, Multicountry, Multicenter Study of Zemplar Injections in Patients With End Stage Chronic Kidney Disease, Undergoing Hemodialysis, Not Adequately Controlled With Oral Vitamin D Receptor Activator (Calcitriol or Alfacalcidol)

Conditions
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Parathyroid Hormone

Intervention / Treatment
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* Drug: Zemplar iv (paricalcitol iv)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is more than 18 years of age and diagnosed with secondary hyperparathyroidism and has a pretreatment iPTH > 300 pg/mL, receiving chronic hemodialysis. Subject for which treatment with Zemplar Injection is indicated clinically according to the criteria of participating investigator. Exclusion Criteria: Subject has a corrected serum calcium >10.5 mg/dL, serum phosphorus > 6.5 mg/dL or subjects with corrected Ca x P>65. Subject has known hypersensitivity and/or toxicity to vitamin D metabolites and/or other product ingredients, or has participated in clinical study within the last month

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 |
| --- | --- |
| End stage chronic kidney disease<br>Secondary hyperparathyroidism defined as intact PTH > 300 pg/mL | Drug: Zemplar iv (paricalcitol iv)<br>* Each patient will be treated at the physician's discretion. Zemplar (paricalcitol) will be prescribed in the usual manner in accordance with the approved Summary of Product Characteristics.<br>* Other names: Zemplar iv;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline |  | Baseline through 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL) | Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit. | Baseline through 12 months | 
| Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL | The average time (measured in days) to achieve target iPTH levels. | Baseline through 12 months | 
| Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements. | Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study. | Baseline through 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paricalcitol iv, vitamin D, secondary hyperparathyroidism, hemodialysis