Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01224782
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Chronic Kidney Disease Secondary Hyperparathyroidism

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 994 participants
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 Start Date : October 2010
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224782


Locations
Show Show 69 study locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Layout table for investigator information
Study Director: Corina Ionescu, MD AbbVie
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01224782    
Other Study ID Numbers: P12-269
First Posted: October 20, 2010    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Zemplar capsules
Chronic kidney disease (CKD) stage 3 or 4
Secondary hyperparathyroidism (SHPT)
Postmarketing observational study (PMOS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Urologic Diseases
 Neoplastic Processes
Neoplasms
Pathologic Processes
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases