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
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|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|
|Actual Primary Completion Date :||June 2013|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|