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Renal Insufficiency

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Female Urogenital Diseases and Pregnancy Complications

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Chronic Graft Versus Host Disease

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

Corina Ionescu, MD

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.

Evaluation of Treatment With Zemplar Capsules in the Therapy of Secondary Hyperparathyroidism (SHPT)

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.

Mean time to achieve a \> 30% decrease in intact parathyroid hormone (iPTH) compared with the initial values at baseline (screening visit).

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.

The percentage of participants with a decrease in iPTH levels \> 30% at any timepoint during followup, 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.

Compliance was assessed using the mean weekly total dose of Zemplar (paricalcitol).

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.

AbbVie (prior sponsor, Abbott)

Chronic Kidney Disease, Secondary Hyperparathyroidism

Age, Continuous

Sex: Female, Male

Chronic Kidney Disease Stage 3

Chronic Kidney Disease Stage 4

Stage 3: Glomerular Filtration Rate 30 - 59 mL/min/1.73 m\^2; Stage 4: Glomerular Filtration Rate 15 - 29 mL/min/1.73 m\^2.

Baseline Chronic Kidney Disease Stage

Baseline Intact Parathyroid Hormone (iPTH)

Global Medical Services

The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study, with a \> 30% decrease in iPTH compared with the initial values at baseline.

Time to Achieve a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH) Values

The primary analysis was conducted in the per-protocol (PP) population, which included all participants for whom all study criteria were fulfilled at the time of enrollment and who had no major protocol deviation occur in the course of the study.

Percentage of Participants With Calcium x Phosphorus Product (CxP) Values > 65 mg˄2/dL˄2 or 5.24 mmol˄2/L˄2

Secondary analyses were conducted in the intent-to-treat (ITT) population, which included all participants who received at least 1 dose of study drug and with available data.

Percentage of Participants Who Achieved a > 30% Decrease From Baseline in Intact Parathyroid Hormone (iPTH)

The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug.

Percentage of Participants With Hypercalcemia

Screening to Month 1 (N=994)

Month 9 to Month 12 (N=737)

Mean Weekly Dose of Zemplar (Paricalcitol)

Any AE

Any Serious AE

Deaths

Adverse Events Probably Related

AEs Possibly Related to Study Drug

AEs Probably Not Related to Study Drug

AEs Not Related to Study Drug

The safety population included all participants who received at least 1 dose of study drug and for whom safety data was collected after administration of the first dose of study drug .

Spots Global Cancer Trial Database for chronic kidney disease (ckd) stage 3 or 4