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
|ClinicalTrials.gov Identifier: NCT01073462|
Recruitment Status : Completed
First Posted : February 23, 2010
Results First Posted : July 10, 2014
Last Update Posted : July 10, 2014
|Condition or disease|
|Secondary Hyperparathyroidism Chronic Kidney Disease Stage V Cardiac Morbidity|
|Study Type :||Observational|
|Actual Enrollment :||67 participants|
|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.|
|Study Start Date :||December 2008|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
- Renin-Angiotensin-Aldosterone System (RAAS) inhibitors
- 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.
- Number of Participants With Cardiac Disease Progression [ Time Frame: Month 3, 6, 12, 18, and 24 ]Cardiac disease progression was determined by the Investigator.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01073462
|Site Reference ID/Investigator# 27447|
|Graz, Austria, 8010|
|Site Reference ID/Investigator# 49182|
|Graz, Austria, 8020|
|Site Reference ID/Investigator# 27483|
|Graz, Austria, 80360|
|Site Reference ID/Investigator# 52742|
|Graz, Austria, 8052|
|Site Reference ID/Investigator# 27487|
|Innsbruck, Austria, 6020|
|Site Reference ID/Investigator# 36983|
|Linz, Austria, 4010|
|Site Reference ID/Investigator# 27484|
|Linz, Austria, 4020|
|Site Reference ID/Investigator# 27485|
|Rottenmann, Austria, 8786|
|Site Reference ID/Investigator# 27446|
|Vienna, Austria, 1030|
|Site Reference ID/Investigator# 53469|
|Vienna, Austria, 1090|
|Site Reference ID/Investigator# 27482|
|Vienna, Austria, 1130|
|Site Reference ID/Investigator# 10981|
|Vienna, Austria, 1220|
|Study Director:||Astrid Dworan-Timler||AbbVie Austria|