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 (CAPITOL)
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|ClinicalTrials.gov Identifier: NCT01265992|
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : February 19, 2014
Last Update Posted : February 19, 2014
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.
|Condition or disease|
|Secondary Hyperparathyroidism Chronic Kidney Disease|
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|
|Actual Enrollment :||50 participants|
|Official Title:||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)|
|Study Start Date :||February 2011|
|Primary Completion Date :||November 2012|
|Study Completion Date :||November 2012|
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.
- 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 [ Time Frame: 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.
- Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months [ Time Frame: 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.
- Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months [ Time Frame: 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.
- Change From Baseline in Proteinuria [ Time Frame: Baseline and Month 6 ]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.
- 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) [ Time Frame: Baseline and 6 months ]
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.
- Total Direct Costs of Care Associated With Secondary Hyperparathyroidism [ Time Frame: 6 months ]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.
- Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism [ Time Frame: 6 months ]
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.
- Number of Participants Using Concomitant Medications at Baseline [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265992
|Site Reference ID/Investigator# 47723|
|Kalmar, Sweden, 391 85|
|Site Reference ID/Investigator# 41084|
|Karlstad, Sweden, 651 85|
|Site Reference ID/Investigator# 45190|
|Kristianstad, Sweden, 291 85|
|Site Reference ID/Investigator# 41085|
|Linkoping, Sweden, 581 85|
|Site Reference ID/Investigator# 41087|
|Norrkoping, Sweden, 601 82|
|Site Reference ID/Investigator# 45188|
|Orebro, Sweden, 701 85|
|Site Reference ID/Investigator# 41088|
|Skovde, Sweden, 541 85|
|Site Reference ID/Investigator# 57782|
|Stockholm, Sweden, 112 81|
|Site Reference ID/Investigator# 41089|
|Varnamo, Sweden, 331 85|
|Site Reference ID/Investigator# 45191|
|Vasteras, Sweden, 721 89|
|Study Director:||Eva Dahl, MD||AbbVie|