Secondary HyperparathyroidismCAPITOLNCT01265992

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

An observational study of Secondary Hyperparathyroidism and Chronic Kidney Disease, run by AbbVie (prior sponsor, Abbott) at 10 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Secondary Hyperparathyroidism, Chronic Kidney Disease
Type of treatment: Pill or oral medicine
How many people: 50 participants
Where: 10 sitesSweden
Study dates: Feb 2011to Nov 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hospitals with nephrology clinic.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Sweden10 sites

Site Reference ID/Investigator# 47723
Kalmar, 391 85
Site Reference ID/Investigator# 41084
Karlstad, 651 85
Site Reference ID/Investigator# 45190
Kristianstad, 291 85
Site Reference ID/Investigator# 41085
Linköping, 581 85
Site Reference ID/Investigator# 41087
Norrköping, 601 82
Site Reference ID/Investigator# 45188
Örebro, 701 85
Site Reference ID/Investigator# 41088
Skövde, 541 85
Site Reference ID/Investigator# 57782
Stockholm, 112 81
Site Reference ID/Investigator# 41089
Värnamo, 331 85
Site Reference ID/Investigator# 45191
Västerås, 721 89

Other trials in Sweden

About this study

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)

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.

Read the 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.

Conditions: Secondary Hyperparathyroidism, Chronic Kidney Disease
Keywords: Secondary hyperparathyroidism, Mineral and Bone Disorder (CKD-MBD), Chronic Kidney Disease
Medical subject headings: Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic, Calcinosis, Bone Diseases, Chronic Kidney Disease-Mineral and Bone Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01265992
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Intact Parathyroid Hormone at 6 Months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months

Secondary outcomes (6)

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.
Measured: Baseline and Month 6
Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Number of Participants Using Concomitant Medications at Baseline
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2011Nov 2012

First posted24 Dec 2010 (estimated)
Study startFeb 2011
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01265992
Sponsor's protocol ID: P12-270
Acronym: CAPITOL
Status last verified: Jan 2014
First submitted: 29 Nov 2010
Last updated: 19 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder

All Secondary Hyperparathyroidism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01265992
Acronym / sponsor ID: CAPITOL / P12-270
Conditions: Secondary Hyperparathyroidism, Chronic Kidney Disease
Keywords: Secondary hyperparathyroidism, Mineral and Bone Disorder (CKD-MBD), Chronic Kidney Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Pharma Consulting Group AB
Study start: Feb 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 24 Dec 2010 (estimated)
Results: Posted 19 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hospitals with nephrology clinic.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

6 secondary outcomes

Change From Baseline in Proteinuria
Time frame: Baseline and Month 6
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
Total Direct Costs of Care Associated With Secondary Hyperparathyroidism
Time frame: 6 months
Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism
Time frame: 6 months
Number of Participants Using Concomitant Medications at Baseline
Time frame: Baseline

Results and safety

Results posted to the registry on 19 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paricalcitol Capsules	50	41

Primary outcome: Change From Baseline in Intact Parathyroid Hormone at 6 Months

Time frame: Baseline and 6 months. Mean (Standard Deviation). Unit: pmol/L

Measure	Paricalcitol Capsules n = 36
Value	-6.2 (13.0)

Population analysed: Per-Protocol Analysis Set (PPAS), defined as all included participants who received at least 1 dose of paricalcitol capsules and had analyzable data for the primary endpoints, i.e., 5 - 8 months after inclusion, and with available iPTH data at both time points.

Primary outcome: Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months

Time frame: Baseline and 6 months. Number. Unit: percentage of participants

Measure	Paricalcitol Capsules n = 40
Baseline	15.0
6 months	27.5

Population analysed: Per-protocol analysis set. Three participants had missing data at Baseline and one participant had missing data at the 6 month visit; percentages are based on the total number of participants in the per-protocol analysis set (40).

Primary outcome: Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months

Time frame: Baseline and 6 months. Number. Unit: percentage of participants

Measure	Paricalcitol Capsules n = 40
Baseline	15.0
6 months	25.0

Population analysed: Per-protocol analysis set. Two patients had missing s-P data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).

Primary outcome: Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months

Time frame: Baseline and 6 months. Number. Unit: percentage of participants

Measure	Paricalcitol Capsules n = 40
Baseline	42.5
6 months	42.5

Population analysed: Per-protocol analysis set. One participant had missing s-Ca data at Baseline and one participant had missing s-Ca data at month 6; percentages are based on the total number of participants in the per-protocol analysis set (40).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paricalcitol Capsules	12 of 49 (24.5%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Secondary Hyperparathyroidism

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eva Dahl, MD study director

AbbVie

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Secondary Hyperparathyroidism and Chronic Kidney Disease, run by AbbVie (prior sponsor, Abbott) at 10 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Intact Parathyroid Hormone at 6 Months (time frame: Baseline and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01265992.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.