Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
|ClinicalTrials.gov Identifier: NCT01224782|
Recruitment Status : Completed
First Posted : October 20, 2010
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
|Condition or disease|
|Chronic Kidney Disease Secondary Hyperparathyroidism|
|Study Type :||Observational|
|Actual Enrollment :||994 participants|
|Official Title:||Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) Stage 3 or 4 in the Conditions of Routine Clinical Practice. A Multi-country, Multi-center Post Marketing Observational Study in Routine Clinical Use in Eastern European Countries.|
|Study Start Date :||October 2010|
|Primary Completion Date :||August 2013|
|Study Completion Date :||August 2013|
Chronic Kidney Disease, Secondary Hyperparathyroidism
All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
- Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values [ Time Frame: From Baseline up to 12 Months ]Mean time to achieve a > 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
- Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 [ Time Frame: From Baseline up to 12 Months ]The percentage of participants with Calcium x Phosphorus Product (CxP) values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2 at any timepoint during followup, up to 12 months.
- Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) [ Time Frame: From Baseline up to 12 Months ]The percentage of participants with a decrease in iPTH levels > 30% at any timepoint during followup, up to 12 months.
- Percentage of Participants With Hypercalcemia [ Time Frame: From Baseline up to 12 months ]The percentage of participants with hypercalcemia (Calcium > 2.6 mmol/L [10.5 mg/dL]) at any timepoint during followup, up to 12 months.
- Mean Weekly Dose of Zemplar (Paricalcitol) [ Time Frame: From Baseline up to 12 months ]Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
- Number of Participants With Adverse Events (AEs) [ Time Frame: Adverse events were collected from the screening visit to month 12 (total 13 months); Serious Adverse Events were collected from the time that informed consent was obtained to 30 days after last dose of study drug (up to 13 months) ]An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious adverse event (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to Zemplar (paricalcitol) were assessed as being either probably or possibly related by the investigator.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224782
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|Study Director:||Corina Ionescu, MD||AbbVie|