Clinical trial NCT01073462: 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
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease Stage V
Cardiac Morbidity
Keywords: Secondary Hyperparathyroidism (sHPT)
Paricalcitol
Chronic kidney disease stage 5 (CKD stage 5)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Assign Data Management and Biostatistics GmbH
First posted: 2010-02-23
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range
timeFrame: Baseline and Months 3, 6, 12, 18, and 24
Secondary outcomes:
measure: Percentage of Participants With Hypercalcemia
timeFrame: Baseline and Months 3, 6, 12, 18, and 24
measure: Percentage of Participants With Hyperphosphatemia
timeFrame: Baseline and Months 3, 6, 12, 18, and 24
measure: Percentage of Participants With at Least a 30%-Reduction in iPTH Levels
timeFrame: Baseline and Months 3, 6, 12, 18, and 24
measure: Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements
timeFrame: Baseline to Month 24
measure: Percentage of Participants With at Least One Concomitant Medication
timeFrame: 24 months
measure: Percentage of Participants Experiencing Hospitalization
timeFrame: 24 months
measure: Number of Participants With Cardiac Disease Progression
timeFrame: Month 3, 6, 12, 18, and 24
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 27447
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 49182
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 27483
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 52742
city: Innsbruck
country: Austria
facility: Site Reference ID/Investigator# 27487
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 36983
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 27484
city: Rottenmann
country: Austria
facility: Site Reference ID/Investigator# 27485
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27446
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 53469
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 27482
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 10981
Study officials:
affiliation: AbbVie Austria
name: Astrid Dworan-Timler
role: STUDY_DIRECTOR
References: