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)

This study has been completed.
Sponsor:
Collaborator:
Pharma Consulting Group AB
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01265992
First received: November 29, 2010
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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
Secondary Hyperparathyroidism
Chronic Kidney Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change From Baseline in Intact Parathyroid Hormone at 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Change From Baseline in Proteinuria [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitals with nephrology clinic.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265992

Locations
Sweden
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
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Pharma Consulting Group AB
Investigators
Study Director: Eva Dahl, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01265992     History of Changes
Other Study ID Numbers: P12-270
Study First Received: November 29, 2010
Results First Received: November 8, 2013
Last Updated: January 22, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by AbbVie:
Secondary hyperparathyroidism
Mineral and Bone Disorder (CKD-MBD)
Chronic Kidney Disease

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 31, 2014