Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pharma Consulting Group AB | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 & 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden.
This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care.
This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed in accordance with the terms of the marketing authorization for patients with Chronic Kidney Disease (CKD) Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care. A retrospective chart review of patient laboratory and medication history will provide historical data to determine drivers for initiation of paricalcitol therapy.
The primary goal of this post-marketing observational study (PMOS) is to further characterize the prescribing habits and patient management practices of physicians prescribing paricalcitol capsules and to assess the metabolic safety and effectiveness of paricalcitol capsules for the treatment of secondary hyperparathyroidism in Stage 3-5 CKD patients not yet on dialysis under conditions of usual clinical care. Focus will be to examine the practice of dose titration in early stages of CKD, understand real-world management of intact parathyroid hormone levels, understand real-world incidence and management of abnormalities in serum calcium and phosphate, and to examine patient bone and mineral profiles and medical history to understand drivers for paricalcitol capsules use.
Patients prescribed paricalcitol therapy for the first time will be asked to participate in the study. Enrolled patients will be followed for 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol capsules | Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Intact Parathyroid Hormone at 6 Months | Baseline and 6 months | |
| Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months | Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are: Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 - 59 mL/min): 3.85 - 7.7 pmol/L; Stage 4 CKD (eGFR 15 - 29 mL/min): 7.7 - 12.1 pmol/L; Stage 5 CKD (eGFR < 15 mL/min): 16.5 - 33 pmol/L. *Calculated using the Modification of Diet in Renal Disease formula. | Baseline and 6 months |
| Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months | Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as: Stage 3 CKD: ≥ 1.49 mmol/L; Stage 4 CKD: ≥ 1.49 mmol/L; Stage 5 CKD: > 1.78 mmol/L. | Baseline and 6 months |
| Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months | Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Proteinuria | Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine. | Baseline and Month 6 |
| Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline |
Not provided
Inclusion Criteria:
Patients must sign the Informed Consent Form prior to inclusion into the study
Exclusion Criteria:
Not provided
Not provided
Not provided
Hospitals with nephrology clinic.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva Dahl, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 47723 | Kalmar | 391 85 | Sweden | |||
| Site Reference ID/Investigator# 41084 |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol Capsules | Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline and 6 months |
| Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) | The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 ("worst possible health") to 10 ("best possible health"). Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life. | Baseline and 6 months |
| Total Direct Costs of Care Associated With Secondary Hyperparathyroidism | Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation. | 6 months |
| Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism | Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days. Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment. Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature. | 6 months |
| Number of Participants Using Concomitant Medications at Baseline | Baseline |
| Karlstad |
| 651 85 |
| Sweden |
| Site Reference ID/Investigator# 45190 | Kristianstad | 291 85 | Sweden |
| Site Reference ID/Investigator# 41085 | Linköping | 581 85 | Sweden |
| Site Reference ID/Investigator# 41087 | Norrköping | 601 82 | Sweden |
| Site Reference ID/Investigator# 45188 | Örebro | 701 85 | Sweden |
| Site Reference ID/Investigator# 41088 | Skövde | 541 85 | Sweden |
| Site Reference ID/Investigator# 57782 | Stockholm | 112 81 | Sweden |
| Site Reference ID/Investigator# 41089 | Värnamo | 331 85 | Sweden |
| Site Reference ID/Investigator# 45191 | Västerås | 721 89 | Sweden |
| Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set, defined as all included participants who received at least 1 dose of paricalcitol capsules.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol Capsules | Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change From Baseline in Intact Parathyroid Hormone at 6 Months | Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points. | Posted | Mean | Standard Deviation | pmol/L | Baseline and 6 months |
|
|
| ||||||||||||||||||||||||||
| Primary | Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months | Kidney Disease Outcomes Quality Initiative (K/DOQI) target intact parathyroid hormone (iPTH) levels are: Stage 3 CKD (estimated Glomerular Filtration Rate* [eGFR] 30 - 59 mL/min): 3.85 - 7.7 pmol/L; Stage 4 CKD (eGFR 15 - 29 mL/min): 7.7 - 12.1 pmol/L; Stage 5 CKD (eGFR < 15 mL/min): 16.5 - 33 pmol/L. *Calculated using the Modification of Diet in Renal Disease formula. | Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40). | Posted | Number | percentage of participants | Baseline and 6 months |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months | Elevated serum phosphorus is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions as: Stage 3 CKD: ≥ 1.49 mmol/L; Stage 4 CKD: ≥ 1.49 mmol/L; Stage 5 CKD: > 1.78 mmol/L. | Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40). | Posted | Number | percentage of participants | Baseline and 6 months |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months | Elevated serum calcium is defined according to the 2003 Kidney Disease Outcomes Quality Initiative (K/DOQI) target definitions of s-Ca above 2.37 mmol/L. | Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40). | Posted | Number | percentage of participants | Baseline and 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Proteinuria | Proteinuria is the presence of excess serum proteins, or albumin, in the urine. Proteinuria was measured by the amount of albumin per liter of urine. | Per-protocol analysis set with available data at both time points. | Posted | Mean | Standard Deviation | g/L | Baseline and Month 6 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline | Per-protocol analysis set. Percentages are based on the total number of participants in the per-protocol analysis set. | Posted | Number | percentage of participants | Baseline and 6 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF) | The KDQOL-SF is a self-report measure developed for individuals with kidney disease. It includes 43 end-stage renal disease (ESRD)-targeted items focused on particular areas of concern for individuals with kidney disease (Symptoms/problems, Effects of the disease on daily life, Burden of disease, Work status, Cognitive function, Quality of social interaction, Sexual function, Sleep, and Social support), 36 items (SF-36) that provide 8 measures of physical and mental health (Physical functioning, Role limitations caused by physical health limitations, Role limitations caused by emotional health problems, Social functioning, Emotional well-being, Pain, Energy/fatigue and General health perceptions), and 1 overall health rating item where respondents rate their health on a scale from 0 ("worst possible health") to 10 ("best possible health"). Scores are transformed and calculated such that each scale score ranges from 0 to 100 where higher scores reflect a better quality of life. | Per-protocol analysis set with available data at both time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6 months |
| |||||||||||||||||||||||||||
| Secondary | Total Direct Costs of Care Associated With Secondary Hyperparathyroidism | Direct medical costs to be calculated included outpatient visits, hospitalizations, pharmaceuticals, etc. However the data collected in this observational study was not enough to support this calculation. | Posted | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism | Indirect costs were estimated by using the number of hours missed from work (absenteeism) multiplied by the average hourly labor cost, including wages and benefits, to calculate average lost productivity costs due to absenteeism during the preceding 7 days. Hours missed from work were assessed using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH) questionnaire, in which respondents answer 6 questions related to work productivity and impairment. Unit costs were taken from official sources (Statistics Sweden, www.scb.se) and published literature. | Participants who were working for pay and with available data at both time points. | Posted | Mean | Standard Deviation | Swedish krona per participant | 6 months |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants Using Concomitant Medications at Baseline | Full analysis set | Posted | Number | participants | Baseline |
|
|
6 months
Only Serious Adverse Events (SAEs) were collected in this Post Marketing Observational Study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paricalcitol Capsules | Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden. | 12 | 49 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (16.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Coordination abnormal | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA (16.0) | Non-systematic Assessment |
|
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D051436 | Renal Insufficiency, Chronic |
| D002114 | Calcinosis |
| D001847 | Bone Diseases |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| 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 |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009140 | Musculoskeletal Diseases |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| Asian |
|
| American (Indian/Alaska Native) |
|
| Other |
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| Agents acting on the renin-angiotensin system |
| |||||
| All other therapeutic products |
| |||||
| Angiotensin II antagonists, plain |
| |||||
| Antianemic preparations |
| |||||
| Antigout preparations |
| |||||
| Antihypertensives |
| |||||
| Antiprotozoals |
| |||||
| Antithrombotic agents |
| |||||
| Beta blocking agents |
| |||||
| Blood substitutes and perfusion solutions |
| |||||
| Calcium channel blockers |
| |||||
| Calcium homeostasis |
| |||||
| Cardiac therapy |
| |||||
| Diuretics |
| |||||
| Drugs for obstructive airway diseases |
| |||||
| Drugs used in diabetes |
| |||||
| Immunosuppressive agents |
| |||||
| Lipid modifying agents |
| |||||
| Mineral supplements |
| |||||
| Vitamins |
|