Chronic Kidney DiseaseNCT01224782

Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

An observational study of Chronic Kidney Disease and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott) at 69 sites in 3 countries.

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

The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve > 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, Secondary Hyperparathyroidism
Type of treatment: Pill or oral medicine
How many people: 994 participants
Where: 69 sitesin 3 countries
Study dates: Oct 2010to Aug 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: Zemplar capsules will be prescribed in usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not prescribe Zemplar capsules would be made prior to entry of a subject in the study. Medical doctors with experience in treatment of patients with chronic kidney disease (CKD) stage 3 or 4 and secondary hyperparathyroidism (SHPT) will observe each enrolled patient for a period of 12 months. Follow-up of patients should enable 6 patient visits during this period.

Who may be able to join

Patients 18 years of age or older
Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT)
Patients with Intact Parathyroid Hormone (iPTH) > 70 pg/mL and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) > 110 pg/mL and with chronic kidney disease (CKD) stage 4
Patients clinically indicated for treatment with Zemplar capsules
Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements are to be followed

Who cannot join

Patients with clinically important hypercalcemia = Calcium > 2.6 mmol/L (10.5 mg/dL)
Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product

Trial locations and contacts

69 sites in 3 countries.

Country

City, postcode or hospital

69 sites in 3 countries

Romania32 sites

Site Reference ID/Investigator# 42992
Bacau
Site Reference ID/Investigator# 42879
Bucharest, 010731
Site Reference ID/Investigator# 42880
Bucharest, 010731
Site Reference ID/Investigator# 42881
Bucharest, 010731
Site Reference ID/Investigator# 42882
Bucharest, 010731
Site Reference ID/Investigator# 42883
Bucharest, 010731
Site Reference ID/Investigator# 42963
Bucharest, 010731
Site Reference ID/Investigator# 42970
Bucharest, 022328
Site Reference ID/Investigator# 42877
Bucharest
Site Reference ID/Investigator# 42878
Bucharest
Site Reference ID/Investigator# 42973
Bucharest
Site Reference ID/Investigator# 42975
Bucharest
Site Reference ID/Investigator# 42976
Bucharest
Site Reference ID/Investigator# 42981
Cluj-Napoca, 400006
Site Reference ID/Investigator# 42982
Cluj-Napoca, 400006
Site Reference ID/Investigator# 42980
Cluj-Napoca, 400139
Site Reference ID/Investigator# 63623
Cluj-Napoca, 400139
Site Reference ID/Investigator# 43009
Constanța, 900591
Site Reference ID/Investigator# 43002
Craiova, 200642
Site Reference ID/Investigator# 43003
Craiova, 200642
Site Reference ID/Investigator# 43006
Craiova, 200642
Site Reference ID/Investigator# 42991
Iași, 700503
Site Reference ID/Investigator# 42988
Iași
Site Reference ID/Investigator# 42989
Iași
Site Reference ID/Investigator# 42999
Oradea, 410450
Site Reference ID/Investigator# 43000
Oradea, 410450
Site Reference ID/Investigator# 42979
Ploieşti, 100097
Site Reference ID/Investigator# 42984
Târgu Mureş
Site Reference ID/Investigator# 42985
Târgu Mureş
Site Reference ID/Investigator# 42987
Târgu Mureş
Site Reference ID/Investigator# 42994
Timișoara
Site Reference ID/Investigator# 42995
Timișoara

Other trials in Romania

Czechia28 sites

Site Reference ID/Investigator# 43449
Beroun, 266 01
Site Reference ID/Investigator# 46744
Brno, 602 00
Site Reference ID/Investigator# 73353
Brno, 602 00
Site Reference ID/Investigator# 47690
Brno, 61500
Site Reference ID/Investigator# 46742
České Budějovice, 370 01
Site Reference ID/Investigator# 49542
Frýdek-Místek, 738 01
Site Reference ID/Investigator# 67442
Jilemnice, 514 15
Site Reference ID/Investigator# 67443
Jilemnice, 514 15
Site Reference ID/Investigator# 51003
Karlovy Vary, 360 66
Site Reference ID/Investigator# 51004
Mariánské Lázně, 353 01
Site Reference ID/Investigator# 43522
Nový Jičín, 74101
Site Reference ID/Investigator# 43523
Nový Jičín, 74101
Site Reference ID/Investigator# 43524
Nový Jičín, 74101
Site Reference ID/Investigator# 45483
Olomouc, 779 00
Site Reference ID/Investigator# 43453
Ostrava, 700 30
Site Reference ID/Investigator# 46743
Pilsen, 323 18
Site Reference ID/Investigator# 51008
Prague, 10034
Site Reference ID/Investigator# 47842
Prague, 118 00
Site Reference ID/Investigator# 68462
Prague, 140 00
Site Reference ID/Investigator# 51005
Prague, 15006
Site Reference ID/Investigator# 51009
Prague
Site Reference ID/Investigator# 51011
Prague
Site Reference ID/Investigator# 48210
Přerov, 750 02
Site Reference ID/Investigator# 45487
Rakovník, 269 29
Site Reference ID/Investigator# 51012
Slaný
Site Reference ID/Investigator# 51002
Sokolov, 356 01
Site Reference ID/Investigator# 43448
Trutnov, 541 21
Site Reference ID/Investigator# 45485
Vyškov, 682 01

Other trials in Czechia

Bulgaria9 sites

Site Reference ID/Investigator# 66544
Montana, 3400
Site Reference ID/Investigator# 47685
Pleven, 5800
Site Reference ID/Investigator# 66546
Plovdiv, 4001
Site Reference ID/Investigator# 47683
Sofia, 1257
Site Reference ID/Investigator# 66543
Sofia, 1407
Site Reference ID/Investigator# 47684
Sofia, 1431
Site Reference ID/Investigator# 66542
Sofia, 1431
Site Reference ID/Investigator# 66545
Sofia, 1709
Site Reference ID/Investigator# 47687
Varna, 9010

Other trials in Bulgaria

About this study

Official title: Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries.

Read the detailed description

This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms of the local marketing authorization. Follow up visits will occur 1, 3, 6, 9, and 12 months after screening.

Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords: Zemplar capsules, Chronic kidney disease (CKD) stage 3 or 4, Secondary hyperparathyroidism (SHPT), Postmarketing observational study (PMOS)
Medical subject headings: Renal Insufficiency, Chronic, Hyperparathyroidism, Secondary

What participants receive

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

Study groups in NCT01224782
Study group	Role	What they receive
Chronic Kidney Disease, Secondary Hyperparathyroidism		All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization

What is being measured

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

Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Measured: From Baseline up to 12 Months
Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2
The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.
Measured: From Baseline up to 12 Months

Secondary outcomes (4)

Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)
The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.
Measured: From Baseline up to 12 Months
Percentage of Participants With Hypercalcemia
The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.
Measured: From Baseline up to 12 months
Mean Weekly Dose of Zemplar (Paricalcitol)
Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
Measured: From Baseline up to 12 months
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.
Measured: Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months)

Timeline

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

Oct 2010Aug 2013

First posted20 Oct 2010 (estimated)
Study startOct 2010
Primary completionAug 2013
Study completionAug 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 Chronic Kidney DiseaseStudies 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
Enrolment: 994 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01224782
Sponsor's protocol ID: P12-269
Status last verified: Sep 2014
First submitted: 27 Sep 2010
Last updated: 15 Sep 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

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries.
ClinicalTrials.gov ID: NCT01224782
Acronym / sponsor ID: P12-269
Conditions: Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords: Zemplar capsules, Chronic kidney disease (CKD) stage 3 or 4, Secondary hyperparathyroidism (SHPT), Postmarketing observational study (PMOS)
Study type: Observational
Recruitment status: Completed
Enrolment: 994 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 20 Oct 2010 (estimated)
Results: Posted 15 Sep 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

Study design

Number of arms: 1

Arm	Type	Receives
Chronic Kidney Disease, Secondary Hyperparathyroidism	–	–All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Zemplar capsules will be prescribed in usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not prescribe Zemplar capsules would be made prior to entry of a subject in the study. Medical doctors with experience in treatment of patients with chronic kidney disease (CKD) stage 3 or 4 and secondary hyperparathyroidism (SHPT) will observe each enrolled patient for a period of 12 months. Follow-up of patients should enable 6 patient visits during this period.

Key inclusion criteria (5 listed)

Patients 18 years of age or older
Patients with chronic kidney disease (CKD) stage 3 and 4 and secondary hyperparathyroidism (SHPT)
Patients with Intact Parathyroid Hormone (iPTH) > 70 pg/mL and with chronic kidney disease (CKD) stage 3 or with Intact Parathyroid Hormone (iPTH) > 110 pg/mL and with chronic kidney disease (CKD) stage 4
Patients clinically indicated for treatment with Zemplar capsules
Patient must provide the authorization to use his/her data for statistical evaluation before entering to the post marketing observational study (PMOS). Local Law requirements are to be followed

Key exclusion criteria (2 listed)

Patients with clinically important hypercalcemia = Calcium > 2.6 mmol/L (10.5 mg/dL)
Patients suffering from proved intoxication of vitamin D or patient with known hypersensitivity to paricalcitol or any other part of the product

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

Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
Time frame: From Baseline up to 12 Months
Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2
Time frame: From Baseline up to 12 Months
The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.

4 secondary outcomes

Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)
Time frame: From Baseline up to 12 Months
Percentage of Participants With Hypercalcemia
Time frame: From Baseline up to 12 months
Mean Weekly Dose of Zemplar (Paricalcitol)
Time frame: From Baseline up to 12 months
Number of Participants With Adverse Events (AEs)
Time frame: Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months)

Results and safety

Results posted to the registry on 15 Sep 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
Chronic Kidney Disease, Secondary Hyperparathyroidism	994	730

Primary outcome: Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values

Time frame: From Baseline up to 12 Months. Mean (Standard Deviation). Unit: months

Measure	Chronic Kidney Disease, Secondary Hyperparathyroidism n = 694
Value	3.82 (3.37)

Population analysed: The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a \> 30% decrease in iPTH compared with the initial values at baseline.

Primary outcome: Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2

Time frame: From Baseline up to 12 Months. Number. Unit: percentage of participants

Measure	Chronic Kidney Disease, Secondary Hyperparathyroidism n = 919
Value	7.4

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.. Other adverse events reported at 0.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Kidney Disease, Secondary Hyperparathyroidism	27 of 994 (2.7%)	66 of 994 (6.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Berger Disease, Bergers Disease
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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.

Corina Ionescu, MD study director

AbbVie

69 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease and Secondary Hyperparathyroidism, run by AbbVie (prior sponsor, Abbott) at 69 sites in 3 countries.

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 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 15 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in Romania, Czechia, Bulgaria. 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 15 Sep 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?

Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values (time frame: From Baseline up to 12 Months). The study lists 2 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 NCT01224782.

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 15 Sep 2014.