- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01073462
Study to Evaluate the Effect of Intravenous (IV) Paricalcitol (Zemplar) on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years
June 9, 2014 updated by: AbbVie (prior sponsor, Abbott)
Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.
The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.
Study Overview
Status
Completed
Detailed Description
Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage 5 receiving dialysis.
SHPT is an adaptive response to CKD and is characterized by an elevation in parathyroid hormone (PTH) and consecutively high calcium levels.
Elevations in calcium levels, phosphate levels, and PTH are correlated with CKD disease progression as well as development or aggravation of cardiovascular impairment.
Many CKD patients cannot be treated well with Vitamin D analogues because of effects on calcium.
Hypercalcemia is a well - known factor for cardiac disease.
No data are available in Austria for a cohort with cardiac disease treated with Zemplar (paricalcitol IV).
Study Type
Observational
Enrollment (Actual)
67
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8010
- Site Reference ID/Investigator# 27447
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Graz, Austria, 8020
- Site Reference ID/Investigator# 49182
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Graz, Austria, 80360
- Site Reference ID/Investigator# 27483
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Graz, Austria, 8052
- Site Reference ID/Investigator# 52742
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Innsbruck, Austria, 6020
- Site Reference ID/Investigator# 27487
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Linz, Austria, 4010
- Site Reference ID/Investigator# 36983
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Linz, Austria, 4020
- Site Reference ID/Investigator# 27484
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Rottenmann, Austria, 8786
- Site Reference ID/Investigator# 27485
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Vienna, Austria, 1030
- Site Reference ID/Investigator# 27446
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Vienna, Austria, 1090
- Site Reference ID/Investigator# 53469
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Vienna, Austria, 1130
- Site Reference ID/Investigator# 27482
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Vienna, Austria, 1220
- Site Reference ID/Investigator# 10981
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.
Description
Inclusion Criteria:
- Patients aged at least 18 years
- Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL,
Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) terms:
- cardiac disorder as cardiac arrhythmias
- cardiac disorder signs and symptoms
- cardiac neoplasm
- cardiac valve disorder
- heart failures
- myocardial disorder
- pericardial disorder
- Serum phosphate level < 6.5 mg/dL and serum calcium level < 10.5 mg/dL
Exclusion Criteria:
- Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol IV) summary of product characteristics
- Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Paricalcitol IV
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
Time Frame: Baseline and Months 3, 6, 12, 18, and 24
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Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).
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Baseline and Months 3, 6, 12, 18, and 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Hypercalcemia
Time Frame: Baseline and Months 3, 6, 12, 18, and 24
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Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement.
Serum calcium was measured at every study visit.
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Baseline and Months 3, 6, 12, 18, and 24
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Percentage of Participants With Hyperphosphatemia
Time Frame: Baseline and Months 3, 6, 12, 18, and 24
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Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement.
Serum phosphate was measured at every study visit.
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Baseline and Months 3, 6, 12, 18, and 24
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Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Time Frame: Baseline and Months 3, 6, 12, 18, and 24
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The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.
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Baseline and Months 3, 6, 12, 18, and 24
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Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements
Time Frame: Baseline to Month 24
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The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.
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Baseline to Month 24
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Percentage of Participants With at Least One Concomitant Medication
Time Frame: 24 months
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The percentage of participants with at least one concomitant medication during the course of the study, by the following types:
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24 months
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Percentage of Participants Experiencing Hospitalization
Time Frame: 24 months
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The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.
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24 months
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Number of Participants With Cardiac Disease Progression
Time Frame: Month 3, 6, 12, 18, and 24
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Cardiac disease progression was determined by the Investigator.
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Month 3, 6, 12, 18, and 24
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Astrid Dworan-Timler, AbbVie Austria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
February 20, 2010
First Submitted That Met QC Criteria
February 22, 2010
First Posted (Estimate)
February 23, 2010
Study Record Updates
Last Update Posted (Estimate)
July 10, 2014
Last Update Submitted That Met QC Criteria
June 9, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P10-680
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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