Clinical trial 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease
Keywords: Secondary hyperparathyroidism
Mineral and Bone Disorder (CKD-MBD)
Chronic Kidney Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Pharma Consulting Group AB
First posted: 2010-12-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals with nephrology clinic.

Brief summary: 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: 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 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

Primary outcomes:
measure: Change From Baseline in Intact Parathyroid Hormone at 6 Months
timeFrame: Baseline and 6 months
measure: Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months
timeFrame: Baseline and 6 months
measure: Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Proteinuria
timeFrame: Baseline and Month 6
measure: Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline
timeFrame: Baseline and 6 months
measure: Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)
timeFrame: Baseline and 6 months
measure: Total Direct Costs of Care Associated With Secondary Hyperparathyroidism
timeFrame: 6 months
measure: Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism
timeFrame: 6 months
measure: Number of Participants Using Concomitant Medications at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Site Reference ID/Investigator# 47723
city: Karlstad
country: Sweden
facility: Site Reference ID/Investigator# 41084
city: Kristianstad
country: Sweden
facility: Site Reference ID/Investigator# 45190
city: Linkoping
country: Sweden
facility: Site Reference ID/Investigator# 41085
city: Norrkoping
country: Sweden
facility: Site Reference ID/Investigator# 41087
city: Orebro
country: Sweden
facility: Site Reference ID/Investigator# 45188
city: Skovde
country: Sweden
facility: Site Reference ID/Investigator# 41088
city: Stockholm
country: Sweden
facility: Site Reference ID/Investigator# 57782
city: Varnamo
country: Sweden
facility: Site Reference ID/Investigator# 41089
city: Vasteras
country: Sweden
facility: Site Reference ID/Investigator# 45191
Study officials:
affiliation: AbbVie
name: Eva Dahl, MD
role: STUDY_DIRECTOR
References: