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

This study has been completed.
Sponsor:
Collaborator:
Assign Data Management and Biostatistics GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01073462
First received: February 20, 2010
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

The purpose of this study was to ascertain the percentage of cardiac patients with chronic kidney disease (CKD) stage 5 treated with paricalcitol IV achieving intact parathyroid hormone (iPTH) levels in target range of Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines (150 - 300 pg/mL) after 2 years.


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 IV) on Cardiac Morbidity in Patients With Chronic Kidney Disease Stage 5 Over 2 Years.

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range [ Time Frame: Baseline and Months 3, 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Target range of intact parathyroid hormone was defined according to the Kidney Disease Outcomes Quality Initiative (K/DOQI) treatment guidelines as between 15.9 - 31.8 pmol/L (150 to 300 pg/mL).


Secondary Outcome Measures:
  • Percentage of Participants With Hypercalcemia [ Time Frame: Baseline and Months 3, 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Hypercalcemia was defined as a calcium value of > 2.625 mmol/L (10.5 mg/dL) in one measurement. Serum calcium was measured at every study visit.

  • Percentage of Participants With Hyperphosphatemia [ Time Frame: Baseline and Months 3, 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Hyperphosphatemia was defined as a phosphate value of > 2.1 mmol/L (6.5 mg/dL) in one measurement. Serum phosphate was measured at every study visit.

  • Percentage of Participants With at Least a 30%-Reduction in iPTH Levels [ Time Frame: Baseline and Months 3, 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.

  • Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.

  • Percentage of Participants With at Least One Concomitant Medication [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    The percentage of participants with at least one concomitant medication during the course of the study, by the following types:

    • Phosphate binder
    • Epoetin
    • Renin-Angiotensin-Aldosterone System (RAAS) inhibitors
    • Cinacalcet
    • Other

  • Percentage of Participants Experiencing Hospitalization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The percentage of participants with at least one hospitalization, at least one cardiac-related hospitalization and at least one non-cardiac-related hospitalization during the course of the study.

  • Number of Participants With Cardiac Disease Progression [ Time Frame: Month 3, 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
    Cardiac disease progression was determined by the Investigator.


Enrollment: 67
Study Start Date: December 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Paricalcitol IV
Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.

Detailed Description:

Secondary hyperparathyroidism (SHPT) is a frequent complication in patients with chronic kidney disease (CKD) stage 5 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 levels, phosphate 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 Vitamin D analogues 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 IV).

  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

Investigational sites were clinic centers with experience in the treatment of chronic kidney disease stage 5 patients and hemodialysis.

Criteria

Inclusion Criteria:

  • Patients aged at least 18 years
  • Patients with secondary hyperparathyroidism associated with CKD stage 5, serum iPTH > 150 pg/mL,
  • Cardiac disease as described by Medical Dictionary for Regulatory Activities (MedDRA) 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 IV) summary of product characteristics
  • Patients with known hypersensitivity to paricalcitol or any component of the formulation, vitamin D intoxication, hypercalcemia; cinacalcet as concomitant medication.
  Contacts and Locations
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, see Learn About Clinical Studies.

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# 27482
Vienna, Austria, 1130
Site Reference ID/Investigator# 27446
Vienna, Austria, 1030
Site Reference ID/Investigator# 10981
Vienna, Austria, 1220
Site Reference ID/Investigator# 53469
Vienna, Austria, 1090
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Assign Data Management and Biostatistics GmbH
Investigators
Study Director: Astrid Dworan-Timler AbbVie Austria
  More Information

Additional Information:
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
Results First Received: June 9, 2014
Last Updated: June 9, 2014
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
Parathyroid Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 01, 2014