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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End stage chronic kidney disease | Secondary hyperparathyroidism defined as intact PTH > 300 pg/mL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zemplar iv (paricalcitol iv) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline | Baseline through 12 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Haemodialysis patients
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| Name | Affiliation | Role |
|---|---|---|
| Marta Gunjaca, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 27525 | Dubrovnik | 20000 | Croatia | |||
| Site Reference ID/Investigator# 27531 |
Safety population consists of 181 participants who received at least one dose of drug. Of those, 175 were included in the full analysis set. Six participants were excluded; five due to initial intact parathyroid hormone values less than 300 picograms per milliliter and one suffered a serious adverse event before the first evaluation (study visit).
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| ID | Title | Description |
|---|---|---|
| FG000 | End Stage Chronic Kidney Disease | Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 |
| Imotski |
| 21260 |
| Croatia |
| Site Reference ID/Investigator# 6175 | Karlovac | 47000 | Croatia |
| Site Reference ID/Investigator# 27528 | Pula | 52100 | Croatia |
| Site Reference ID/Investigator# 27533 | Rijeka | 51000 | Croatia |
| Site Reference ID/Investigator# 27523 | Sisak | 44000 | Croatia |
| Site Reference ID/Investigator# 27529 | Slavonski Brod | 35000 | Croatia |
| Site Reference ID/Investigator# 27530 | Split | 1000 | Croatia |
| Site Reference ID/Investigator# 27524 | Šibenik | 22000 | Croatia |
| Site Reference ID/Investigator# 27534 | Trogir | 21220 | Croatia |
| Site Reference ID/Investigator# 27522 | Vinkovci | 32000 | Croatia |
| Site Reference ID/Investigator# 27527 | Zadar | 23000 | Croatia |
| Site Reference ID/Investigator# 27526 | Zagreb | 10000 | Croatia |
| Site Reference ID/Investigator# 27532 | Zagreb | 10000 | Croatia |
| Site Reference ID/Investigator# 27536 | Belgrade | 11000 | Serbia |
| Site Reference ID/Investigator# 27538 | Belgrade | 11000 | Serbia |
| Site Reference ID/Investigator# 27539 | Belgrade | 11000 | Serbia |
| Site Reference ID/Investigator# 6169 | Belgrade | 11000 | Serbia |
| Site Reference ID/Investigator# 27540 | Belgrade | 11080 | Serbia |
| Site Reference ID/Investigator# 27535 | Bor | 19210 | Serbia |
| Site Reference ID/Investigator# 27537 | Kragujevac | 34000 | Serbia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | End Stage Chronic Kidney Disease | Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline | Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data. | Posted | Number | percentage of participants | Baseline through 12 months |
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| Secondary | 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. | Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data. | Posted | Number | percentage of participants | Baseline through 12 months |
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| Secondary | 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. | Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data. | Posted | Mean | Standard Deviation | Days | Baseline through 12 months |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | Analysis was based on the number of subjects included in the full analysis set (N=175). | Posted | Number | participants | Baseline through 12 months |
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Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | End Stage Chronic Kidney Disease | Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics. | 15 | 181 | 20 | 181 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiopulmonary arrest | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Hypertension | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Pulmonary edema | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
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| Parathyroid adenoma | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Paresis | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Spinal cord neoplasm | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 13.1 | Systematic Assessment | Reason for death is unknown, assessed as not related to study drug. |
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| Bronchopneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Cancer of lung | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Pulmonary embolism | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Radial artery embolism | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Thrombosis arteriovenous fistula | Vascular disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastritis chronic | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
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| Hyperphosphaetemia | Endocrine disorders | MedDRA 13.1 | Systematic Assessment |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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