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

Completed

• Conditions: Cardiac Morbidity; Chronic Kidney Disease Stage V; Secondary Hyperparathyroidism

• Registration Number: NCT01073462
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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).

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-02-20
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-23
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-06
• Results First Submitted: 2014-06-09
• Results First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Results First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range	Baseline and Months 3, 6, 12, 18, and 24	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

Name	Time	Method
Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements	Baseline to Month 24	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 Hyperphosphatemia	Baseline and Months 3, 6, 12, 18, and 24	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 Hypercalcemia	Baseline and Months 3, 6, 12, 18, and 24	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 at Least a 30%-Reduction in iPTH Levels	Baseline and Months 3, 6, 12, 18, and 24	The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.
Number of Participants With Cardiac Disease Progression	Month 3, 6, 12, 18, and 24	Cardiac disease progression was determined by the Investigator.
Percentage of Participants Experiencing Hospitalization	24 months	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.
Percentage of Participants With at Least One Concomitant Medication	24 months	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

Trial Locations

Locations (12)

Site Reference ID/Investigator# 27482; 🇦🇹 Vienna, Austria

Site Reference ID/Investigator# 10981; 🇦🇹 Vienna, Austria

Site Reference ID/Investigator# 27487; 🇦🇹 Innsbruck, Austria

Site Reference ID/Investigator# 27447; 🇦🇹 Graz, Austria

Site Reference ID/Investigator# 49182; 🇦🇹 Graz, Austria

Site Reference ID/Investigator# 27483; 🇦🇹 Graz, Austria

Site Reference ID/Investigator# 52742; 🇦🇹 Graz, Austria

Site Reference ID/Investigator# 36983; 🇦🇹 Linz, Austria

Site Reference ID/Investigator# 27484; 🇦🇹 Linz, Austria

Site Reference ID/Investigator# 27485; 🇦🇹 Rottenmann, Austria

Site Reference ID/Investigator# 27446; 🇦🇹 Vienna, Austria

Site Reference ID/Investigator# 53469; 🇦🇹 Vienna, Austria