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

September 12, 2014 updated by: AbbVie (prior sponsor, Abbott)

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.

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 secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

994

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

  • Bulgaria
      • Montana, Bulgaria, 3400
        • Site Reference ID/Investigator# 66544
      • Pleven, Bulgaria, 5800
        • Site Reference ID/Investigator# 47685
      • Plovdiv, Bulgaria, 4001
        • Site Reference ID/Investigator# 66546
      • Sofia, Bulgaria, 1257
        • Site Reference ID/Investigator# 47683
      • Sofia, Bulgaria, 1407
        • Site Reference ID/Investigator# 66543
      • Sofia, Bulgaria, 1431
        • Site Reference ID/Investigator# 47684
      • Sofia, Bulgaria, 1431
        • Site Reference ID/Investigator# 66542
      • Sofia, Bulgaria, 1709
        • Site Reference ID/Investigator# 66545
      • Varna, Bulgaria, 9010
        • Site Reference ID/Investigator# 47687
  • Czech Republic
      • Beroun, Czech Republic, 266 01
        • Site Reference ID/Investigator# 43449
      • Brno, Czech Republic, 602 00
        • Site Reference ID/Investigator# 46744
      • Brno, Czech Republic, 602 00
        • Site Reference ID/Investigator# 73353
      • Brno, Czech Republic, 61500
        • Site Reference ID/Investigator# 47690
      • Budejovice, Czech Republic, 370 01
        • Site Reference ID/Investigator# 46742
      • Frydek-Mistek, Czech Republic, 738 01
        • Site Reference ID/Investigator# 49542
      • Jilemnice, Czech Republic, 514 15
        • Site Reference ID/Investigator# 67442
      • Jilemnice, Czech Republic, 514 15
        • Site Reference ID/Investigator# 67443
      • Karlovy Vary, Czech Republic, 360 66
        • Site Reference ID/Investigator# 51003
      • Marianske Lazne, Czech Republic, 353 01
        • Site Reference ID/Investigator# 51004
      • Novy Jicin, Czech Republic, 74101
        • Site Reference ID/Investigator# 43522
      • Novy Jicin, Czech Republic, 74101
        • Site Reference ID/Investigator# 43523
      • Novy Jicin, Czech Republic, 74101
        • Site Reference ID/Investigator# 43524
      • Olomouc, Czech Republic, 779 00
        • Site Reference ID/Investigator# 45483
      • Ostrava, Czech Republic, 700 30
        • Site Reference ID/Investigator# 43453
      • Plzen, Czech Republic, 323 18
        • Site Reference ID/Investigator# 46743
      • Prague 1, Czech Republic, 118 00
        • Site Reference ID/Investigator# 47842
      • Prague 10, Czech Republic, 10034
        • Site Reference ID/Investigator# 51008
      • Prague 4, Czech Republic, 140 00
        • Site Reference ID/Investigator# 68462
      • Prague 4, Czech Republic
        • Site Reference ID/Investigator# 51009
      • Prague 5, Czech Republic, 15006
        • Site Reference ID/Investigator# 51005
      • Prague 9, Czech Republic
        • Site Reference ID/Investigator# 51011
      • Prerov, Czech Republic, 750 02
        • Site Reference ID/Investigator# 48210
      • Rakovnik, Czech Republic, 269 29
        • Site Reference ID/Investigator# 45487
      • Slany, Czech Republic
        • Site Reference ID/Investigator# 51012
      • Sokolov, Czech Republic, 356 01
        • Site Reference ID/Investigator# 51002
      • Trutnov, Czech Republic, 541 21
        • Site Reference ID/Investigator# 43448
      • Vyskov, Czech Republic, 682 01
        • Site Reference ID/Investigator# 45485
  • Romania
      • Bacau, Romania
        • Site Reference ID/Investigator# 42992
      • Bucharest, Romania, 010731
        • Site Reference ID/Investigator# 42879
      • Bucharest, Romania, 010731
        • Site Reference ID/Investigator# 42880
      • Bucharest, Romania, 010731
        • Site Reference ID/Investigator# 42881
      • Bucharest, Romania, 010731
        • Site Reference ID/Investigator# 42882
      • Bucharest, Romania, 010731
        • Site Reference ID/Investigator# 42883
      • Bucharest, Romania, 010731
        • Site Reference ID/Investigator# 42963
      • Bucharest, Romania, 022328
        • Site Reference ID/Investigator# 42970
      • Bucharest, Romania
        • Site Reference ID/Investigator# 42877
      • Bucharest, Romania
        • Site Reference ID/Investigator# 42878
      • Bucharest, Romania
        • Site Reference ID/Investigator# 42973
      • Bucharest, Romania
        • Site Reference ID/Investigator# 42975
      • Bucharest, Romania
        • Site Reference ID/Investigator# 42976
      • Cluj-Napoca, Romania, 400006
        • Site Reference ID/Investigator# 42981
      • Cluj-Napoca, Romania, 400006
        • Site Reference ID/Investigator# 42982
      • Cluj-Napoca, Romania, 400139
        • Site Reference ID/Investigator# 42980
      • Cluj-Napoca, Romania, 400139
        • Site Reference ID/Investigator# 63623
      • Constanta, Romania, 900591
        • Site Reference ID/Investigator# 43009
      • Craiova, Romania, 200642
        • Site Reference ID/Investigator# 43002
      • Craiova, Romania, 200642
        • Site Reference ID/Investigator# 43003
      • Craiova, Romania, 200642
        • Site Reference ID/Investigator# 43006
      • Iasi, Romania, 700503
        • Site Reference ID/Investigator# 42991
      • Iasi, Romania
        • Site Reference ID/Investigator# 42988
      • Iasi, Romania
        • Site Reference ID/Investigator# 42989
      • Oradea, Romania, 410450
        • Site Reference ID/Investigator# 42999
      • Oradea, Romania, 410450
        • Site Reference ID/Investigator# 43000
      • Ploiesti, Romania, 100097
        • Site Reference ID/Investigator# 42979
      • Targu Mures, Romania
        • Site Reference ID/Investigator# 42984
      • Targu Mures, Romania
        • Site Reference ID/Investigator# 42985
      • Targu Mures, Romania
        • Site Reference ID/Investigator# 42987
      • Timisoara, Romania
        • Site Reference ID/Investigator# 42994
      • Timisoara, Romania
        • Site Reference ID/Investigator# 42995

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

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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?

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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.
From Baseline up to 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)
Time Frame: From Baseline up to 12 Months
The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.
From Baseline up to 12 Months
Percentage of Participants With Hypercalcemia
Time Frame: From Baseline up to 12 months
The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.
From Baseline up to 12 months
Mean Weekly Dose of Zemplar (Paricalcitol)
Time Frame: From Baseline up to 12 months
Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
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)
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Corina Ionescu, MD, AbbVie

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

October 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 27, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 12, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-269

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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