search
Back to results

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

Primary Purpose

Chronic Kidney Disease, Secondary Hyperparathyroidism

Status
Completed
Phase
Locations
International
Study Type
Observational
Intervention
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Chronic Kidney Disease focused on measuring Zemplar capsules, Chronic kidney disease (CKD) stage 3 or 4, Secondary hyperparathyroidism (SHPT), Postmarketing observational study (PMOS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 66544
  • Site Reference ID/Investigator# 47685
  • Site Reference ID/Investigator# 66546
  • Site Reference ID/Investigator# 47683
  • Site Reference ID/Investigator# 66543
  • Site Reference ID/Investigator# 47684
  • Site Reference ID/Investigator# 66542
  • Site Reference ID/Investigator# 66545
  • Site Reference ID/Investigator# 47687
  • Site Reference ID/Investigator# 43449
  • Site Reference ID/Investigator# 46744
  • Site Reference ID/Investigator# 73353
  • Site Reference ID/Investigator# 47690
  • Site Reference ID/Investigator# 46742
  • Site Reference ID/Investigator# 49542
  • Site Reference ID/Investigator# 67442
  • Site Reference ID/Investigator# 67443
  • Site Reference ID/Investigator# 51003
  • Site Reference ID/Investigator# 51004
  • Site Reference ID/Investigator# 43522
  • Site Reference ID/Investigator# 43523
  • Site Reference ID/Investigator# 43524
  • Site Reference ID/Investigator# 45483
  • Site Reference ID/Investigator# 43453
  • Site Reference ID/Investigator# 46743
  • Site Reference ID/Investigator# 51008
  • Site Reference ID/Investigator# 47842
  • Site Reference ID/Investigator# 68462
  • Site Reference ID/Investigator# 51009
  • Site Reference ID/Investigator# 51005
  • Site Reference ID/Investigator# 51011
  • Site Reference ID/Investigator# 48210
  • Site Reference ID/Investigator# 45487
  • Site Reference ID/Investigator# 51012
  • Site Reference ID/Investigator# 51002
  • Site Reference ID/Investigator# 43448
  • Site Reference ID/Investigator# 45485
  • Site Reference ID/Investigator# 42992
  • Site Reference ID/Investigator# 42879
  • Site Reference ID/Investigator# 42880
  • Site Reference ID/Investigator# 42881
  • Site Reference ID/Investigator# 42882
  • Site Reference ID/Investigator# 42883
  • Site Reference ID/Investigator# 42963
  • Site Reference ID/Investigator# 42970
  • Site Reference ID/Investigator# 42877
  • Site Reference ID/Investigator# 42878
  • Site Reference ID/Investigator# 42973
  • Site Reference ID/Investigator# 42975
  • Site Reference ID/Investigator# 42976
  • Site Reference ID/Investigator# 42981
  • Site Reference ID/Investigator# 42982
  • Site Reference ID/Investigator# 42980
  • Site Reference ID/Investigator# 63623
  • Site Reference ID/Investigator# 43009
  • Site Reference ID/Investigator# 43002
  • Site Reference ID/Investigator# 43003
  • Site Reference ID/Investigator# 43006
  • Site Reference ID/Investigator# 42991
  • Site Reference ID/Investigator# 42988
  • Site Reference ID/Investigator# 42989
  • Site Reference ID/Investigator# 42999
  • Site Reference ID/Investigator# 43000
  • Site Reference ID/Investigator# 42979
  • Site Reference ID/Investigator# 42984
  • Site Reference ID/Investigator# 42985
  • Site Reference ID/Investigator# 42987
  • Site Reference ID/Investigator# 42994
  • Site Reference ID/Investigator# 42995

Arms of the Study

Arm 1

Arm Type

Arm Label

Chronic Kidney Disease, Secondary Hyperparathyroidism

Arm Description

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

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
Mean Weekly Dose of Zemplar (Paricalcitol)
Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
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.

Full Information

First Posted
September 27, 2010
Last Updated
September 12, 2014
Sponsor
AbbVie (prior sponsor, Abbott)
search

1. Study Identification

Unique Protocol Identification Number
NCT01224782
Brief Title
Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
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.
Study Type
Observational

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Secondary Hyperparathyroidism
Keywords
Zemplar capsules, Chronic kidney disease (CKD) stage 3 or 4, Secondary hyperparathyroidism (SHPT), Postmarketing observational study (PMOS)

7. Study Design

Enrollment
994 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Kidney Disease, Secondary Hyperparathyroidism
Arm Description
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
Primary Outcome Measure Information:
Title
Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
Description
Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Time Frame
From Baseline up to 12 Months
Title
Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2
Description
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.
Time Frame
From Baseline up to 12 Months
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)
Description
The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.
Time Frame
From Baseline up to 12 Months
Title
Percentage of Participants With Hypercalcemia
Description
The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.
Time Frame
From Baseline up to 12 months
Title
Mean Weekly Dose of Zemplar (Paricalcitol)
Description
Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
Time Frame
From Baseline up to 12 months
Title
Number of Participants With Adverse Events (AEs)
Description
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.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
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.
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corina Ionescu, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 66544
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 47685
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 66546
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 47683
City
Sofia
ZIP/Postal Code
1257
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 66543
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 47684
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 66542
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 66545
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 47687
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 43449
City
Beroun
ZIP/Postal Code
266 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 46744
City
Brno
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 73353
City
Brno
ZIP/Postal Code
602 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 47690
City
Brno
ZIP/Postal Code
61500
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 46742
City
Budejovice
ZIP/Postal Code
370 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 49542
City
Frydek-Mistek
ZIP/Postal Code
738 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 67442
City
Jilemnice
ZIP/Postal Code
514 15
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 67443
City
Jilemnice
ZIP/Postal Code
514 15
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51003
City
Karlovy Vary
ZIP/Postal Code
360 66
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51004
City
Marianske Lazne
ZIP/Postal Code
353 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 43522
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 43523
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 43524
City
Novy Jicin
ZIP/Postal Code
74101
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 45483
City
Olomouc
ZIP/Postal Code
779 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 43453
City
Ostrava
ZIP/Postal Code
700 30
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 46743
City
Plzen
ZIP/Postal Code
323 18
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51008
City
Prague 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 47842
City
Prague 1
ZIP/Postal Code
118 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 68462
City
Prague 4
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51009
City
Prague 4
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51005
City
Prague 5
ZIP/Postal Code
15006
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51011
City
Prague 9
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 48210
City
Prerov
ZIP/Postal Code
750 02
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 45487
City
Rakovnik
ZIP/Postal Code
269 29
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51012
City
Slany
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 51002
City
Sokolov
ZIP/Postal Code
356 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 43448
City
Trutnov
ZIP/Postal Code
541 21
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 45485
City
Vyskov
ZIP/Postal Code
682 01
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 42992
City
Bacau
Country
Romania
Facility Name
Site Reference ID/Investigator# 42879
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Site Reference ID/Investigator# 42880
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Site Reference ID/Investigator# 42881
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Site Reference ID/Investigator# 42882
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Site Reference ID/Investigator# 42883
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Site Reference ID/Investigator# 42963
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Site Reference ID/Investigator# 42970
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Site Reference ID/Investigator# 42877
City
Bucharest
Country
Romania
Facility Name
Site Reference ID/Investigator# 42878
City
Bucharest
Country
Romania
Facility Name
Site Reference ID/Investigator# 42973
City
Bucharest
Country
Romania
Facility Name
Site Reference ID/Investigator# 42975
City
Bucharest
Country
Romania
Facility Name
Site Reference ID/Investigator# 42976
City
Bucharest
Country
Romania
Facility Name
Site Reference ID/Investigator# 42981
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Site Reference ID/Investigator# 42982
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Site Reference ID/Investigator# 42980
City
Cluj-Napoca
ZIP/Postal Code
400139
Country
Romania
Facility Name
Site Reference ID/Investigator# 63623
City
Cluj-Napoca
ZIP/Postal Code
400139
Country
Romania
Facility Name
Site Reference ID/Investigator# 43009
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Facility Name
Site Reference ID/Investigator# 43002
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Site Reference ID/Investigator# 43003
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Site Reference ID/Investigator# 43006
City
Craiova
ZIP/Postal Code
200642
Country
Romania
Facility Name
Site Reference ID/Investigator# 42991
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Site Reference ID/Investigator# 42988
City
Iasi
Country
Romania
Facility Name
Site Reference ID/Investigator# 42989
City
Iasi
Country
Romania
Facility Name
Site Reference ID/Investigator# 42999
City
Oradea
ZIP/Postal Code
410450
Country
Romania
Facility Name
Site Reference ID/Investigator# 43000
City
Oradea
ZIP/Postal Code
410450
Country
Romania
Facility Name
Site Reference ID/Investigator# 42979
City
Ploiesti
ZIP/Postal Code
100097
Country
Romania
Facility Name
Site Reference ID/Investigator# 42984
City
Targu Mures
Country
Romania
Facility Name
Site Reference ID/Investigator# 42985
City
Targu Mures
Country
Romania
Facility Name
Site Reference ID/Investigator# 42987
City
Targu Mures
Country
Romania
Facility Name
Site Reference ID/Investigator# 42994
City
Timisoara
Country
Romania
Facility Name
Site Reference ID/Investigator# 42995
City
Timisoara
Country
Romania

12. IPD Sharing Statement

Links:
URL
http://rxabbvie.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs