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

AbbVie (prior sponsor, Abbott)67 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Secondary Hyperparathyroidism Chronic Kidney Disease Stage V Cardiac Morbidity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

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# 27487

Innsbruck, 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

...and 2 more locations

Outcomes

Primary Outcomes

Percentage of Participants Achieving an Intact Parathyroid Hormone (iPTH) Level Within the Target Range

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).

Time frame: Baseline and Months 3, 6, 12, 18, and 24

Secondary Outcomes

Percentage of Participants With Hypercalcemia

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.

Time frame: Baseline and Months 3, 6, 12, 18, and 24

Percentage of Participants With Hyperphosphatemia

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.

Time frame: Baseline and Months 3, 6, 12, 18, and 24

Percentage of Participants With at Least a 30%-Reduction in iPTH Levels

The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) levels from Baseline level.

Time frame: Baseline and Months 3, 6, 12, 18, and 24

Percentage of Participants With at Least 30%-Reduction in iPTH Levels in at Least Two Consecutive Measurements

The percentage of participants with at least a 30% reduction in intact parathyroid hormone (iPTH) level from Baseline in at least 2 consecutive visits.

Time frame: Baseline to Month 24

Percentage of Participants With at Least One Concomitant Medication

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

Time frame: 24 months

Percentage of Participants Experiencing Hospitalization

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.

Time frame: 24 months

Number of Participants With Cardiac Disease Progression

Cardiac disease progression was determined by the Investigator.

Time frame: Month 3, 6, 12, 18, and 24