The aims of this post-marketing observational study (PMOS) are to evaluate the time period needed to achieve \> 30% decrease of intact parathyroid hormone (iPTH) compared to the initial values and to provide data on the tolerability and compliance of treatment with Zemplar (paricalcitol) capsules in the therapy of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) stage 3 or 4 in conditions of routine clinical practice.
This is a non-interventional, observational, open-label, multi-country, multicenter post-marketing study in which Zemplar (paricalcitol) is prescribed in the usual manner in accordance with the terms of the local marketing authorization. Follow up visits will occur 1, 3, 6, 9, and 12 months after screening.
Study Type
OBSERVATIONAL
Enrollment
994
Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values
Mean time to achieve a \> 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).
Time frame: From Baseline up to 12 Months
Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2
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.
Time frame: From Baseline up to 12 Months
Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)
The percentage of participants with a decrease in iPTH levels \> 30% at any timepoint during followup, up to 12 months.
Time frame: From Baseline up to 12 Months
Percentage of Participants With Hypercalcemia
The percentage of participants with hypercalcemia (Calcium \> 2.6 mmol/L \[10.5 mg/dL\]) at any timepoint during followup, up to 12 months.
Time frame: From Baseline up to 12 months
Mean Weekly Dose of Zemplar (Paricalcitol)
Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).
Time frame: From Baseline up to 12 months
Number of Participants With Adverse Events (AEs)
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.
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Site Reference ID/Investigator# 66544
Montana, Bulgaria
Site Reference ID/Investigator# 47685
Pleven, Bulgaria
Site Reference ID/Investigator# 66546
Plovdiv, Bulgaria
Site Reference ID/Investigator# 47683
Sofia, Bulgaria
Site Reference ID/Investigator# 66543
Sofia, Bulgaria
Site Reference ID/Investigator# 47684
Sofia, Bulgaria
Site Reference ID/Investigator# 66542
Sofia, Bulgaria
Site Reference ID/Investigator# 66545
Sofia, Bulgaria
Site Reference ID/Investigator# 47687
Varna, Bulgaria
Site Reference ID/Investigator# 43449
Beroun, Czechia
...and 59 more locations
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)