Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)
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|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|
|Actual Primary Completion Date :||August 2013|
|Actual 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.
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): NCT01224782
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|Study Director:||Corina Ionescu, MD||AbbVie|