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| Name | Class |
|---|---|
| Planimeter Ltd | UNKNOWN |
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This observational study will evaluate the clinical benefit of Zemplar (paricalcitol injection) in daily routine practice in end-stage renal disease patients with severe over-reactivity of parathyroid glands. Participants will be followed for 6 months. Data will be collected from participants initiated on Zemplar therapy according to standard of care. The time to achieving the maintenance dose of Zemplar (paricalcitol injection), the proportion of participants achieving target parathyroid hormone levels, and prevalence of elevated serum calcium and phosphate levels will be evaluated.
Prospective data collection started at initial dosing with Zemplar (paricalcitol injection) and ended up to 6 months later. If available, retrospective data on vitamin D treatment as well as on the incidence of hypercalcaemia and hyperphosphataemia in the 6 months leading up to paricalcitol treatment were also collected. Eight visits were planned for documentation of prospective data. In accordance with the non-interventional character of the study, only diagnostic and monitoring procedures were applied which are part of the routine medical care of secondary hyperparathyroidism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| End-stage kidney disease with secondary hyperparathyroidism | Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT) |
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| Measure | Description | Time Frame |
|---|---|---|
| Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) | Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 | Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L. | 6 months |
| Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance |
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Inclusion Criteria:
Based on the current Hungarian Summary of Product Characteristics for Zemplar (paricalcitol injection), the patient is entitled to treatment with paricalcitol injection and:
≥ 18 years of age,
Willing to sign the patient information and informed consent form,
Chronic kidney disease (CKD) stage 5 patient receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT), whose intact parathyroid hormone (iPTH) level is:
The patient is planned to receive paricalcitol treatment independently from his/her participation in this study.
Exclusion Criteria:
Patients cannot be enrolled in the study if any of the following exclusion criteria apply:
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Stage 5 chronic kidney disease patients treated in haemodialysis centers in Hungary
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| Name | Affiliation | Role |
|---|---|---|
| Tamas Schnaider | AbbVie (prior sponsor, Abbott) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 46593 | Budapest | 1083 | Hungary | |||
| Site Reference ID/Investigator# 46585 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | End-stage Kidney Disease With Secondary Hyperparathyroidism | Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. |
| 6 months prior to start of study through 6 months of treatment |
| Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance | If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. | 6 months prior to start of study through 6 months of treatment |
| Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism | If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. | 6 months prior to start of study through 6 months of treatment |
| Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy | Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues). | 6 months prior to start of study through baseline |
| Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection). | 6 months |
| Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy | Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues). | 6 months prior to start of study through baseline |
| Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection). | 6 months |
| Budapest |
| 1115 |
| Hungary |
| Site Reference ID/Investigator# 46594 | Debrecen | 4012 | Hungary |
| Site Reference ID/Investigator# 47722 | Győr | 9023 | Hungary |
| Site Reference ID/Investigator# 46592 | Karcag | 5301 | Hungary |
| Site Reference ID/Investigator# 58644 | Karcag | 5301 | Hungary |
| Site Reference ID/Investigator# 46595 | Miskolc | 3501 | Hungary |
| Site Reference ID/Investigator# 46588 | NyÃregyháza | 4400 | Hungary |
| Site Reference ID/Investigator# 46597 | Pécs | 7624 | Hungary |
| Site Reference ID/Investigator# 46590 | Szombathely | 9700 | Hungary |
| Site Reference ID/Investigator# 46591 | Veszprém | 8200 | Hungary |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | End-stage Kidney Disease With Secondary Hyperparathyroidism | Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT) |
| 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 | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection) | Maintenance dose is defined as weekly dose of paricalcitol that results in at least 2 consecutive intact parathyroid hormone (iPTH) values within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L. | Participants who achieved maintenance dose of Zemplar (paricalcitol injection) | Posted | Mean | Standard Deviation | weeks | 6 months |
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| Secondary | Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6 | Target intact parathyroid hormone (iPTH) values were within the target therapeutic range of 150 - 300 pg/mL, corresponding to 15.9 - 31.8 pmol/L. | All participants | Posted | Number | participants | 6 months |
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| Secondary | Country-Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance | If available, data on vitamin D treatment (those who received vitamin D supplement products from Anatomical Therapeutic Chemical [ATC] group A11CC [vitamin D and analogues]) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. | This outcome measure was not analyzed due to lack of data. | Posted | 6 months prior to start of study through 6 months of treatment |
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| |||||||||||||||||||||||||||||
| Secondary | Country-Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance | If available, data on the use of phosphate binders (those who received calcium-based phosphate binders or sevelamer/lanthanum) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. | This outcome measure was not analyzed due to lack of data. | Posted | 6 months prior to start of study through 6 months of treatment |
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| Secondary | Country-Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism | If available, data on the use of medication affecting secondary hyperparathyroidism (those who received calcimimetics and calcium supplementation) in the 6 months leading up to paricalcitol treatment and during 6 months of paricalcitol treatment were also collected. | This outcome measure was not analyzed due to lack of data. | Posted | 6 months prior to start of study through 6 months of treatment |
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| Secondary | Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy | Hypercalcaemia (serum calcium > 2.6 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues). | Participants with available retrospective data | Posted | Number | participants | 6 months prior to start of study through baseline |
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| Secondary | Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | Hypercalcaemia (serum calcium > 2.6 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection). | Participants with available retrospective data (cohort analyzed for Outcome Measure 6) were analyzed prospectively at Month 6 of treatment. | Posted | Number | participants | 6 months |
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| Secondary | Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy | Hyperphosphataemia (serum phosphorus >1.78 mmol/L) among participants during the preceding 6 months of conventional vitamin D therapy was derived from retrospective data collection in case report form, reported at baseline. Conventional vitamin D therapy included vitamin D supplement products from ATC group A11CC (vitamin D and analogues). | Participants with available retrospective data | Posted | Number | participants | 6 months prior to start of study through baseline |
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| Secondary | Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment | Hyperphosphataemia (serum phosphorus > 1.78 mmol/L), based on laboratory data, was collected during the observed 6 months treatment with Zemplar (paricalcitol injection). | Participants with available retrospective data (cohort analyzed for Outcome Measure 8) were analyzed prospectively at Month 6 of treatment. | Posted | Number | participants | 6 months |
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Reported from informed consent until 30 days or 5 half-lives following intake of last dose of physician-prescribed treatment. Thus, for each participant adverse events were assessed for a maximum of 7 months after the initial dose of Zemplar®.
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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 Kidney Disease With Secondary Hyperparathyroidism | Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT) | 9 | 60 | 16 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Inflammation | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Spinal pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Bronchitis | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Gangrene | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Staphylococcal bacteraemia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Arterial occlusive disease | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Calcium phosphate product increased | Investigations | MedDRA 15.0 | Non-systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hyperphoshataemia | Metabolism and nutrition disorders | MedDRA 15.0 | Non-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 | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
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