Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Symptoms and General Pathology

Gland and Hormone Related Diseases

Rare Diseases

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Neoplasm Metastasis

Hyperparathyroidism

Hyperparathyroidism, Secondary

Kidney Failure, Chronic

Renal Insufficiency

Neoplastic Processes

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Renal Insufficiency, Chronic

Chronic Disease

Disease Attributes

Parathyroid Diseases

Endocrine System Diseases

Chronic Graft Versus Host Disease

All eligible patients treated with IV Paricalcitol (Zemplar)

Konstantinos Xynos, MD

The aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of Zemplar as it is prescribed in the normal clinical setting and according to the approved Summary of Product Characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in Greece.

The primary objective of this study is to evaluate the safety of Zemplar® in the treatment of Secondary hyperparathyroidism (iParathormone\>300 pg/mL) in subjects on hemodialysis treated in conditions of usual clinical care.

The primary safety endpoints of this study are to evaluate the safety of Zemplar by recording the number of hospitalizations and days hospitalized.

A secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. Therapeutic success with Zemplar® will be defined as:

* 40% reduction in the base iPTH level is achieved, and/or;
* serum iParathormone level \< 300 pg/mL.

Additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (Ca) \> 11.0 mg/dL taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (P)\>6.5 mg/dL taken at 2 consecutive measurements), and elevated Ca x P product (defined as serum Ca x P\>65 mg\^2/dL\^2 taken at 2 consecutive measurements). Safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

A Two-year, Post-marketing Observational Study to Follow-up Patients With End Stage Renal Disease Undergoing Haemodialysis, Receiving Zemplar for Prevention and Treatment of Secondary Hyperparathyroidism

The number of participants who were hospitalized during the study and the number of hospitalizations are summarized.

The mean (average) number of days hospitalized per participant for those hospitalized during the study.

Therapeutic success of paricalcitol treatment was defined as a 40% decrease from the baseline measurement in the level of intact parathyroid hormone (also known as iPTH or parathormone) and/or a serum intact parathyroid hormone level less than 300 picograms per milliliter (pg/mL) for at least 2 consecutive available measurements during the 24-month follow-up period.

The number of participants with clinically significant hypercalcemia (too much calcium in the blood), defined as a corrected serum calcium level greater than 11.0 milligrams per deciliter (mg/dL) at 2 consecutive measurements.

The number of participants with clinically significant hyperphosphatemia (too much phosphorous in the blood), defined as serum phosphorous levels greater than 6.5 milligrams per deciliter (mg/dL) at 2 consecutive measurements.

The number of participants with clinically significant levels of calcium-phosphorous product (Ca x P), defined as serum calcium-phosphorous product levels greater than 65 milligrams squared per deciliters squared (mg\^2/dL\^2) at 2 consecutive measurements.

The number of adverse events, serious adverse events (including death), adverse drug reactions, and serious adverse drug reactions experienced by participants during the study are summarized. Adverse events include any events reported regardless of whether or not they were considered related to the study drug. Adverse drug reactions include events where a causal relationship between the drug and the occurence of the event is suspected. For additional details see the Reported Adverse Events section.

Abbott

Chronic Kidney Disease

Age Continuous

Sex: Female, Male

Greece

Region of Enrollment

The age of participants when they were diagnosed with chronic kidney disease. Based on data reported by 222 participants.

Age at chronic kidney disease diagnosis

The amount of time elapsed from the time the participant was diagnosed with chronic kidney disease to study entry. Based on data reported by 222 participants.

Time since chronic kidney disease diagnosis

At study entry, the amount of time that had elapsed from participants first starting haemodialysis, a procedure that filters the blood to remove harmful wastes.

Time since starting haemodialysis

At study entry, the amount of time that had elapsed since participants were first diagnosed with hyperparathyroidism, a condition where the parathyroid glands make too much parathyroid hormone, causing an imbalance of calcium and phosphorous in the body. Based on data reported by 228 participants.

Time since diagnosis of secondary hyperparathyroidism

Global Medical Services

Participants with no hospitalizations

Participants with at least 1 hospitalization

>Participants with 1 hospitalization

>Participants with 2 hospitalizations

>Participants with 3 or more hospitalizations

Analysis included all enrolled participants.

Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations

Analysis based on the evaluable population, defined as participants with baseline and at least 2 post-baseline parathormone measurements at the 24-month post-treatment follow-up visit.

The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)

The Incidence of Clinically Significant Hypercalcemia

The Incidence of Clinically Significant Hyperphosphatemia

The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product

Experienced an adverse event (serious/non-serious)

>Experienced non-serious adverse event

>Experienced serious adverse event

Experienced non-serious adverse drug reaction

Experienced serious adverse drug reaction

Total number of deaths reported

>Number of deaths during the study

>Number of deaths after study completion

Death considered related to study drug

To Estimate the Incidence of (S)AEs/(S)ADRs

Based on participant hospitalizations during the study where the length of hospitalization was known (82 participants total).

Spots Global Cancer Trial Database for chronic kidney failure