Skip to main content
OpenTrials
Completed

NCT Number: 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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Secondary Hyperparathyroidism Cardiac Morbidity Chronic Disease Chronic Kidney Disease Stage V Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site Reference ID/Investigator# 27447, Graz, Austria

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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 outcomes

  1. Percentage of Participants With Hypercalcemia

    Time frame: 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.

  2. Percentage of Participants With Hyperphosphatemia

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Percentage of Participants With at Least One Concomitant Medication

    Time frame: 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

  6. Percentage of Participants Experiencing Hospitalization

    Time frame: 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.

  7. Number of Participants With Cardiac Disease Progression

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

    Cardiac disease progression was determined by the Investigator.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

  • Assign Data Management and Biostatistics GmbH

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 23, 2010
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.