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.
Study Type
OBSERVATIONAL
Enrollment
50
Site Reference ID/Investigator# 47723
Kalmar, Sweden
Site Reference ID/Investigator# 41084
Karlstad, Sweden
Site Reference ID/Investigator# 45190
Kristianstad, Sweden
Site Reference ID/Investigator# 41085
Linköping, Sweden
Site Reference ID/Investigator# 41087
Norrköping, Sweden
Site Reference ID/Investigator# 45188
Örebro, Sweden
Site Reference ID/Investigator# 41088
Skövde, Sweden
Site Reference ID/Investigator# 57782
Stockholm, Sweden
Site Reference ID/Investigator# 41089
Värnamo, Sweden
Site Reference ID/Investigator# 45191
Västerås, Sweden
Change From Baseline in Intact Parathyroid Hormone at 6 Months
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 6 months
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.
Time frame: Baseline and Month 6
Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Number of Participants Using Concomitant Medications at Baseline
Time frame: Baseline
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