The purpose of this study is to obtain data on the use of Zemplar (paricalcitol) capsules in real-life clinical practice in predialysis patients with chronic kidney disease (CKD) and secondary hyperparathyroidism.
This was a single arm, open, multicenter, non-interventional, post marketing observational study, which has been conducted in 24 sites in Greece, under normal clinical practice and as per the locally approved Summary of Product Characteristics (SmPC) of study medication (oral paricalcitol). Eligible patients were followed up for a 12-month period after enrollment. All study activities were consistent with European Union (EU) directive 2001/20/EC section for non-interventional studies. In this study, paricalcitol was prescribed on an on-label basis in an everyday setting to observe drug actions in a distinct geography (Greece with \> 250 days/year of sunny days) as well as in a significant subpopulation (Chronic Kidney Disease \[CKD\] stages 3-5 transplanted patients). Dose tolerability, treatment effects, as well as maintenance of results were registered for a 12-month period in order to obtain experience in the long term use of paricalcitol capsules. Furthermore, in centers where additional blood parameters were examined as part of clinical routine, these were recorded and analyzed.
Study Type
OBSERVATIONAL
Enrollment
500
Site Reference ID/Investigator# 47002
Arta, Greece
Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population
iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the overall study population.
Time frame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants
iPTH levels before and after oral paricalcitol treatment onset were recorded at each study visit, and corresponding changes were calculated for the subpopulation of renal transplanted participants.
Time frame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels
The time to attain the first lower iPTH levels was considered as the time from the date of oral paricalcitol treatment onset until the date when any of the following conditions were initially met: a 30% reduction from iPTH levels prior to treatment onset had been achieved, for patients who were still outside the target range; or iPTH levels equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL; CKD Stage 5: ≤ 300 pg/mL).
Time frame: Measured from start of study, up to a maximum of 12 months
Mean Duration of Effect Sustainability (Months)
The effect was considered sustainable if: the participant's intact parathormone (iPTH) value remained equal or lower to the upper limit of the target range according to Kidney Disease Quality Outcome Initiative (K/DOQI) guidelines (CKD Stage 3: ≤ 70 pg/mL; CKD Stage 4: ≤ 110 pg/mL); or iPTH levels continued to decrease 30% from the previous available measurement.
Time frame: Measured from start of study, up to a maximum of 12 months
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Site Reference ID/Investigator# 43772
Athens, Greece
Site Reference ID/Investigator# 27492
Athens, Greece
Site Reference ID/Investigator# 43769
Athens, Greece
Site Reference ID/Investigator# 38257
Athens, Greece
Site Reference ID/Investigator# 47003
Athens, Greece
Site Reference ID/Investigator# 27497
Athens, Greece
Site Reference ID/Investigator# 47004
Athens, Greece
Site Reference ID/Investigator# 27489
Athens, Greece
Site Reference ID/Investigator# 27495
Athens, Greece
...and 14 more locations
Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range
Number of participants with iPTH levels within the target range of Kidney Disease Quality Outcome Initiative (K/DOQI) treatment guidelines at each study measurement after oral paricalcitol treatment onset. K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
Time frame: Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Number of Participants With Serum Calcium Level Abnormalities
Normal serum calcium range was 8.4-10.2 mg/dL.
Time frame: Baseline, Enrollment Visit, Month 6, Month 12
Number of Participants With Serum Phosphorus Level Abnormalities
Normal serum phosphorus range was 2.7-4.6 mg/dL.
Time frame: Baseline, Enrollment Visit, Month 6, Month 12
Change in Dipstick Albuminuria Grade From Baseline to Month 6
The values "-, Trace, +, ++, and +++" are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.
Time frame: Baseline, Month 6
Change in Dipstick Albuminuria Grade From Baseline to Month 12
The values "-, Trace, +, ++, and +++" are taken directly from the dipstick measurements, and represent a range from none to highest albuminuria. Data presented shows the number of participants with each value both at Baseline and at Month 6.
Time frame: Baseline, Month 12
Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study
The HbA1c normal range was 4.3-6.1%.
Time frame: Baseline, Enrollment Visit, Month 6, Month 12
Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs)
In order to establish the safety profile of oral paricalcitol in daily clinical practice, non-serious adverse events (nSAEs) and serious adverse events (SAEs) were collected during the course of the study. An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above. Please see Adverse Events section below for more details.
Time frame: From time of enrollment throughout the study up to 12 months for nSAEs. SAEs from time of enrollment throughout the study up to + 30 days after end of study.
Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study
Change in CKD stage throughout the study period was assessed by the estimated glomerular filtration rate (eGFR) levels recorded by the physicians at each study time point. Classification of eGFR into CKD stages as follows: CKD stage 2: 60-89 mL/min/1.73m\^2; CKD stage 3: 30-59 mL/min/1.73m\^2; CKD stage 4: 15-29 mL/min/1.73m\^2; CKD stage 5: \<15 mL/min/1.73/m\^2. Table presents the number of participants by stage at each study visit.
Time frame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study
The eGFR normal range was 90-120 mL/min/1.73m\^2.
Time frame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12
The alanine aminotransferase normal range was 11-43 IU/L.
Time frame: Baseline, Month 6, Month 12
Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12
The aspartate aminotransferase normal range was 11-38 IU/L.
Time frame: Baseline, Month 6, Month 12
Change From Baseline in Creatinine Levels at Months 6 and 12
The creatinine normal range was 0.6-1.4 mg/dL.
Time frame: Baseline, Month 6, Month 12
Change From Baseline in Urea Levels at Months 6 and 12
The urea normal range was 10-50 mg/dL.
Time frame: Baseline, Month 6, Month 12
Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12
The alkaline phosphatase normal range was 40-129 IU/L.
Time frame: Baseline, Month 6, Month 12
Change From Enrollment in Total Cholesterol Levels at Months 6 and 12
The total cholesterol normal range was 130-200 mg/dL.
Time frame: Enrollment, Month 6, Month 12
Change From Enrollment in Triglyceride Levels at Months 6 and 12
The normal range for triglycerides was 0-200 mg/dL.
Time frame: Enrollment, Month 6, Month 12
Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12
The LDL-C normal range was 0-150 mg/dL.
Time frame: Enrollment, Month 6, Month 12
Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12
The HDL-C normal range was 35-90 mg/dL.
Time frame: Enrollment, Month 6, Month 12
Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12
The CRP normal range was 0-0.6 mg/dL.
Time frame: Baseline, Month 6, Month 12
Homocysteine Values Throughout the Study
The homocysteine normal range 3.5-20 μmol/L.
Time frame: Baseline, Enrollment Visit, Month 6, Month 12