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

Secondary Hyperparathyroidism Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073462
• Other study ID #: P10-680
• Status: Completed
• Phase: N/A
• First received: February 20, 2010
• Last updated: June 9, 2014
• Start date: December 2008
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Morbidity
• Chronic Kidney Disease Stage V
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Locations

Country	Name	City	State
Austria	Site Reference ID/Investigator# 27447	Graz
Austria	Site Reference ID/Investigator# 27483	Graz
Austria	Site Reference ID/Investigator# 49182	Graz
Austria	Site Reference ID/Investigator# 52742	Graz
Austria	Site Reference ID/Investigator# 27487	Innsbruck
Austria	Site Reference ID/Investigator# 27484	Linz
Austria	Site Reference ID/Investigator# 36983	Linz
Austria	Site Reference ID/Investigator# 27485	Rottenmann
Austria	Site Reference ID/Investigator# 10981	Vienna
Austria	Site Reference ID/Investigator# 27446	Vienna
Austria	Site Reference ID/Investigator# 27482	Vienna
Austria	Site Reference ID/Investigator# 53469	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Assign Data Management and Biostatistics GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and Months 3, 6, 12, 18, and 24	No
Secondary	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.	Baseline and Months 3, 6, 12, 18, and 24	No
Secondary	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.	Baseline and Months 3, 6, 12, 18, and 24	No
Secondary	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.	Baseline and Months 3, 6, 12, 18, and 24	No
Secondary	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.	Baseline to Month 24	No
Secondary	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	24 months	No
Secondary	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.	24 months	No
Secondary	Number of Participants With Cardiac Disease Progression	Cardiac disease progression was determined by the Investigator.	Month 3, 6, 12, 18, and 24	No

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