Secondary HyperparathyroidismNCT01073462
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
An observational study of Secondary Hyperparathyroidism and Chronic Kidney Disease Stage V, run by AbbVie (prior sponsor, Abbott) at 12 sites in Austria.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism, Chronic Kidney Disease Stage V, Cardiac Morbidity
- Type of treatment
- Injection or infusion
- How many people
- 67 participants
- Where
- 12 sitesAustria
- Study dates
- Dec 2008to Jun 2013
- 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: Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.
Who may be able to join
- 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
Show all 11Show fewer
- cardiac valve disorder
- heart failures
- myocardial disorder
- pericardial disorder
- Serum phosphate level < 6.5 mg/dL and serum calcium level < 10.5 mg/dL
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Austria12 sites
Site Reference ID/Investigator# 27447
Graz, 8010
Site Reference ID/Investigator# 49182
Graz, 8020
Site Reference ID/Investigator# 27483
Graz, 80360
Site Reference ID/Investigator# 52742
Graz, 8052
Site Reference ID/Investigator# 27487
Innsbruck, 6020
Site Reference ID/Investigator# 36983
Linz, 4010
Site Reference ID/Investigator# 27484
Linz, 4020
Site Reference ID/Investigator# 27485
Rottenmann, 8786
Site Reference ID/Investigator# 27446
Vienna, 1030
Site Reference ID/Investigator# 53469
Vienna, 1090
Site Reference ID/Investigator# 27482
Vienna, 1130
Site Reference ID/Investigator# 10981
Vienna, 1220
About this study
Official title: 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.
Read the 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).
- Keywords
- Secondary Hyperparathyroidism (sHPT), Paricalcitol, Chronic kidney disease stage 5 (CKD stage 5)
- Medical subject headings
- Hyperparathyroidism, Secondary, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
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).
Measured: Baseline and Months 3, 6, 12, 18, and 24
Secondary outcomes (7)
Percentage of Participants With Hypercalcemia
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.
Measured: Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With Hyperphosphatemia
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.
Measured: Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.
Measured: Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements
The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.
Measured: Baseline to Month 24
Percentage of Participants With at Least One Concomitant Medication
The percentage of participants with at least one concomitant medication during the course of the study, by the following types:
- Phosphate binder
- Epoetin
- Renin-Angiotensin-Aldosterone System (RAAS) inhibitors
- Cinacalcet
- Other
Measured: 24 months
Percentage of Participants Experiencing Hospitalization
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.
Measured: 24 months
Number of Participants With Cardiac Disease Progression
Cardiac disease progression was determined by the Investigator.
Measured: Month 3, 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startDec 2008
- Primary completionJun 2013
- Study completionJun 2013
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Assign Data Management and Biostatistics GmbH
- Responsible party
- Sponsor
- Investigators
- Astrid Dworan-Timler, Study director, AbbVie Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073462
- Sponsor's protocol ID
- P10-680
- Status last verified
- Jun 2014
- First submitted
- 20 Feb 2010
- Last updated
- 10 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01073462
- Acronym / sponsor ID
- P10-680
- Keywords
- Secondary Hyperparathyroidism (sHPT), Paricalcitol, Chronic kidney disease stage 5 (CKD stage 5)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- Assign Data Management and Biostatistics GmbH
- Study start
- Dec 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Posted 10 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
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
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
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).
7 secondary outcomes
Percentage of Participants With Hypercalcemia
Time frame: Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With Hyperphosphatemia
Time frame: Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
Time frame: Baseline and Months 3, 6, 12, 18, and 24
Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements
Time frame: Baseline to Month 24
Percentage of Participants With at Least One Concomitant Medication
Time frame: 24 months
Percentage of Participants Experiencing Hospitalization
Time frame: 24 months
Number of Participants With Cardiac Disease Progression
Time frame: Month 3, 6, 12, 18, and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Secondary Hyperparathyroidism
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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.
Astrid Dworan-Timler study director
AbbVie Austria
12 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 Stage V, run by AbbVie (prior sponsor, Abbott) at 12 sites in Austria.
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 11 inclusion and 2 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 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Austria. 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 10 Jul 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2014.