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Study to Evaluate the Effect of Zemplar on Cardiac Morbidity in Patients With Chronic Kidney Disease (CKD) Stage 5 Over 2 Years

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Assign Group Data Management Biostatistics
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01073462
First received: February 20, 2010
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage V 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 (Ca) levels, phosphor 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 1,25-D 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 I.V.)


Condition
Secondary Hyperparathyroidism
Chronic Kidney Disease Stage V
Cardiac Morbidity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postmarketing Observational Study to Evaluate the Effect of Zemplar (Paricalcitol) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Serum PTH [ Time Frame: At baseline Visit ] [ Designated as safety issue: No ]
  • Serum PTH [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Serum PTH [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Serum PTH [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Serum PTH [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Serum PTH [ Time Frame: month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Calcium [ Time Frame: At baseline Visit ] [ Designated as safety issue: No ]
  • Serum Calcium [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Serum Calcium [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Serum Calcium [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Serum Calcium [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Serum Calcium [ Time Frame: month 24 ] [ Designated as safety issue: No ]
  • Serum Phosphate [ Time Frame: At baseline visit ] [ Designated as safety issue: No ]
  • Serum Phosphate [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Serum Phosphate [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Serum Phosphate [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Serum Phosphate [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Serum Phosphate [ Time Frame: month 24 ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: At baseline visit ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Concomitant Medication [ Time Frame: month 24 ] [ Designated as safety issue: No ]
  • Cardiac Disease is described by MeDRA terms [ Time Frame: At baseline visit ] [ Designated as safety issue: No ]
  • Cardiac Disease is described by MeDRA terms [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Cardiac Disease is described by MeDRA terms [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Cardiac Disease is described by MeDRA terms [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Cardiac Disease is described by MeDRA terms [ Time Frame: month 18 ] [ Designated as safety issue: No ]
  • Cardiac Disease is described by MeDRA terms [ Time Frame: month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic kidney disease stage 5, SHPT, cardiac morbidity
Chronic kidney disease stage 5 with SHPT and cardiac morbidity treated with Zemplar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Dialyse hospital

Criteria

Inclusion Criteria:

  • Patients age > 18 years
  • Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPHT > 150 pg/ml,

  • Cardiac disease as described by MeDRA terms:

    • cardiac disorder as cardiac arrhythmias
    • cardiac disorder signs and symptoms
    • cardiac neoplasm
    • cardiac valve disorder
    • heart failures
    • myocardial disorder
    • pericardial disorder
    • Serum phosphate level < 6,5 mg/dl and serum calcium level < 10,5 mg/dl

Exclusion Criteria:

  • Patients who meet contraindications as outlined in the latest version of Zemplar (Paricalcitol I.V.) SmPC
  • Patients with known hypersensitivity to Paricalcitol or any component of the formulation, vitamin D intoxication, Hypercalcemia; Cinacalcet as concomitant medication
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073462

Locations
Austria
Site Reference ID/Investigator# 52742
Graz, Austria, 8052
Site Reference ID/Investigator# 49182
Graz, Austria, 8020
Site Reference ID/Investigator# 27447
Graz, Austria, 8010
Site Reference ID/Investigator# 27483
Graz, Austria, 80360
Site Reference ID/Investigator# 27487
Innsbruck, Austria, 6020
Site Reference ID/Investigator# 27484
Linz, Austria, 4020
Site Reference ID/Investigator# 36983
Linz, Austria, 4010
Site Reference ID/Investigator# 27485
Rottenmann, Austria, 8786
Site Reference ID/Investigator# 27488
St. Poelten, Austria, 3100
Site Reference ID/Investigator# 27482
Vienna, Austria, 1130
Site Reference ID/Investigator# 53469
Vienna, Austria, 1090
Site Reference ID/Investigator# 10981
Vienna, Austria, 1220
Site Reference ID/Investigator# 27446
Vienna, Austria, 1030
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Assign Group Data Management Biostatistics
Investigators
Study Director: Astrid Dworan-Timler AbbVie Austria
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01073462     History of Changes
Other Study ID Numbers: P10-680
Study First Received: February 20, 2010
Last Updated: April 16, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by AbbVie:
Secondary Hyperparathyroidism (sHPT)
Paricalcitol
Chronic kidney disease stage 5 (CKD stage 5)

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
 Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on June 17, 2013