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NCT Number: NCT01265992

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

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.

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Key information

Conditions

Secondary Hyperparathyroidism Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcinosis Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Rickets Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 47723, Kalmar, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change From Baseline in Intact Parathyroid Hormone at 6 Months

    Time frame: Baseline and 6 months

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline

    Time frame: Baseline and 6 months

  3. 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.

  4. 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.

  5. 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.

  6. Number of Participants Using Concomitant Medications at Baseline

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

  • Pharma Consulting Group AB

Registry information

Official study 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)

Acronym: CAPITOL

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2010
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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