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Changes in country regulation
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This study was designed to evaluate the effectiveness, safety, and impact on quality of life when paricalcitol (Zemplar® intravenous [IV]) is administered in Venezuelan patients on hemodialysis who are at risk of developing secondary hyperparathyroidism associated with stage V chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol IV | Eligible participants with diagnosis of chronic kidney disease stage V undergoing hemodialysis, treated with paricalcitol IV per routine clinical practice according to prescribing information approved in Venezuela and clinical criteria. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit | Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL). |
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Inclusion Criteria:
Exclusion Criteria:
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This study was conducted in 8 hemodialysis units distributed in Venezuela.
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| Name | Affiliation | Role |
|---|---|---|
| Jeanine Obage, MD | Abbott | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 96757 | Acarigua | Venezuela | ||||
| Site Reference ID/Investigator# 96766 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol IV | Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol IV | Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Missing data of one (1) participant, for whom age (years) was not reported. |
| 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 Participants Achieving at Least a 30% Reduction From Baseline in the Levels of Parathyroid Hormone (PTH) at the Final Study Visit | Participants with valid PTH values at Baseline and Final Study Visit. | Posted | Number | percentage of participants | Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit) |
|
|
From time of informed consent until 30 days or 5 half-lives following intake of the last dose of physician-prescribed treatment.
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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 | Paricalcitol IV | Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) |
| Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL | Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24). | Baseline to Week 12, Week 12 to Week 24 |
| Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks | Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24). | Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit) |
| European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state. | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) |
| European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 | The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100). | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) |
| Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit | BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome. | Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit) |
| Barquisimeto |
| Venezuela |
| Site Reference ID/Investigator# 96768 | Caracas | Venezuela |
| Site Reference ID/Investigator# 96760 | Maracaibo | Venezuela |
| Site Reference ID/Investigator# 96761 | Maracaibo | Venezuela |
| Site Reference ID/Investigator# 96770 | Miranda | Venezuela |
| Site Reference ID/Investigator# 96763 | Monagas | Venezuela |
| Site Reference ID/Investigator# 96765 | Naguanagua | Venezuela |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
|
|
| Secondary | Percentage of Participants With Hypercalcemia, Hyperphosphatemia and Elevations of Calcium-Phosphate Product (Ca x P) at Baseline, Week 12, and Week 24 | Hypercalcemia was defined as a value of serum calcium (Ca) greater than or equal to 10.3 mg/dL. Hyperphosphatemia was defined as a value of serum phosphorus (P) greater than or equal to 5.5 mg/dL. Elevated Ca×P was defined as as greater or equal to 56.65 mg^2/dL^2, calculated as the result of multiplying the maximum values of calcium (10.3 mg/dL) and phosphorus (5.5 mg/dL). | Participants with valid assessments at given time point. | Posted | Number | percentage of participants | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) |
|
|
|
| Secondary | Number of Participants Achieving Parathyroid Hormone (PTH) Levels < 300 pg/mL | Participants who achieved PTH Levels < 300 pg/mL between the first and third study visit (Baseline to Week 12) and the third and final study visit (Week 12 to Week 24). | All participants; n=participants with valid PTH values at given time point. | Posted | Number | participants | Baseline to Week 12, Week 12 to Week 24 |
|
|
|
| Secondary | Number of Participants Achieving PTH Level Reductions to < 300 pg/mL or 30% Below Baseline in 12 or 24 Weeks | Number of participants achieving PTH level reductions to < 300 pg/mL or 30% below Baseline in 12 weeks (Baseline to Week 12 or Week 12 to Week 24) or in 24 weeks (Baseline to Week 24). | All participants; n=number of participants with valid PTH values at given time point. | Posted | Number | participants | Baseline Week 1 (Study Visit 1) to Week 24 (Final Study Visit) |
|
|
|
| Secondary | European Quality of Life 5 Dimensions (EQ-5D) Parameters of Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression At Baseline, Week 12, and Week 24 | The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a visual analogue scale (VAS). For each parameter other than the VAS, participants are asked to indicate which of 5 statements (from 'no problem' to 'extreme problem') best describes their health state. | Participants with valid assessments at given time point. | Posted | Number | participants | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) |
|
|
|
| Secondary | European Quality of Life 5 Dimensions (EQ-5D) Visual Analogue Scale (VAS) Scores At Baseline, Week 12, and Week 24 | The EQ-5D questionnaire is an international, standardized, generic instrument for describing and valuing health status that is divided into 5 parameters that include mobility, self-care, usual activities, pain/discomfort, anxiety/depression and a VAS. For the VAS portion, health status is assessed by participants on a vertical, visual analog scale from 0 to 100 where the endpoints are labeled 'worst imaginable health state' (0) and 'best imaginable health state' (100). | Participants with valid assessments at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline Week 1 (Study Visit 1), Week 12 (Study Visit 3), Week 24 (Final Study Visit) |
|
|
|
| Secondary | Beck Depression Inventory (BDI) Scores At Baseline and Final Study Visit | BDI is a 21-item questionnaire, participant self-report rating inventory that measures characteristic attitudes and symptoms of depression. The range of scores is 0 to 63, with a higher value representing a worse outcome. | Participants with a complete, valid assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline Week 1 (Study Visit 1), Week 24 (Final Study Visit) |
|
|
|
| 9 |
| 105 |
| 21 |
| 105 |
| Parathyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Spinal cord compression | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Drowning | Social circumstances | MedDRA 11.1 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neuropathic pain | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
|
| Pain in extremities | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
|
| Chest pain | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
|
| Elevations of (Ca x P) |
|
| Title | Measurements |
|---|---|
|
|
| Mobility: Moderate Problems |
|
| Mobility: Severe Problems |
|
| Mobility: Unable to Walk About |
|
| Mobility: Unknown |
|
| Self-Care: No Problems |
|
| Self-Care: Slight Problems |
|
| Self-Care: Moderate Problems |
|
| Self-Care: Severe Problems |
|
| Self-Care: Unable to Wash or Dress Self |
|
| Self-Care: Unknown |
|
| Usual Activities: No Problems |
|
| Usual Activities: Slight Problems |
|
| Usual Activities: Moderate Problems |
|
| Usual Activities: Severe Problems |
|
| Usual Activities: Unable to Do Usual Activities |
|
| Usual Activities: Unknown |
|
| Pain/Discomfort: None |
|
| Pain/Discomfort: Slight |
|
| Pain/Discomfort: Moderate |
|
| Pain/Discomfort: Severe |
|
| Pain/Discomfort: Extreme |
|
| Pain/Discomfort: Unknown |
|
| Anxiety/Depression: None |
|
| Anxiety/Depression: Slight |
|
| Anxiety/Depression: Moderate |
|
| Anxiety/Depression: Severe |
|
| Anxiety/Depression: Extreme |
|
| Anxiety/Depression: Unknown |
|