Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Post Marketing Observational Study to Assess Patient Management Practices and Quality of Life With the Capsules Form of Paricalcitol in the Treatment of SHPT in Stage 3 - 5 Chronic Kidney Disease Patients Not Yet on Dialysis Under Conditions of Usual Clinical Care (CAPITOL)

Conditions
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Secondary Hyperparathyroidism, Chronic Kidney Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must sign the Informed Consent Form prior to inclusion into the study Patients should satisfy the Swedish Summary of Product Characteristics (SPC) for paricalcitol capsules at www.fass.se Patients must be 18 years or older with a diagnosis of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 - 5 (estimated Glomerular Filtration Rate between 10-59 by Modification of Diet in Renal Disease) but not yet on dialysis Patients should be in stable condition and have a life expectancy of at least 6 months Patients should not be expected to be transplanted or initiate dialysis for at least 6 months Exclusion Criteria: Patients with CKD receiving dialysis Patients contraindicated for paricalcitol capsules as described in the SPC Treatment with paricalcitol more than 20 days prior to study enrollment History of drug or alcohol abuse within 6 months prior to inclusion History of non-compliance with medication or a medical history (i.e. psychiatric) that could enhance non-compliance with medication as determined by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Paricalcitol capsules<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary hyperparathyroidism, Mineral and Bone Disorder (CKD-MBD), Chronic Kidney Disease