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

Status: Completed

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01073462

P10-680

Details and patient eligibility

About

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.

Full 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).

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

67 participants in 1 patient group

Paricalcitol IV

Description:

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.