| Primary | 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. | Overall study population. n=number of participants with available data at given time-point. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
| | | Title | Denominators | Categories |
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| Before Study Treatment (Baseline); n=495 | | | | Visit 1 (Enrollment); n=497 | | | | Visit 2 (3 Months Post-Enrollment); n=432 | |
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| Primary | 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. | Participants with renal transplantation history. n=number of participants with available data at given time-point. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | 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). | Subset of participants with baseline CKD stage ≥ 3 as well as with available iPTH values greater than the upper limit of the target range, prior to paricalcitol treatment onset. Target range for this specific analysis was defined based on patient's CKD stage (per baseline eGFR) prior to paricalcitol treatment onset. | Posted | | Median | 95% Confidence Interval | months | | Measured from start of study, up to a maximum of 12 months | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | 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. | All evaluable participants | Posted | | Mean | Standard Deviation | months | | Measured from start of study, up to a maximum of 12 months | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | 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. | All participants. n=participants with evaluable data at given time point. | Posted | | Number | | participants | | Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | | | | ID | Title | Description |
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| OG000 | Participants Within the iPTH Target Range | Number of participants with iPTH levels within the target range of 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. | | OG001 | Participants Out of the iPTH Target Range | Number of participants with iPTH levels outside of the target range of 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. |
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| Secondary | Number of Participants With Serum Calcium Level Abnormalities | Normal serum calcium range was 8.4-10.2 mg/dL. | All participants. n=number of participants with evaluable data at given time-point. | Posted | | Number | | participants | | Baseline, Enrollment Visit, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Participants Within the Normal Calcium Range | Normal serum calcium range was 8.4-10.2 mg/dL. | | OG001 | Participants Outside of the Normal Calcium Range | Normal serum calcium range was 8.4-10.2 mg/dL. |
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| Secondary | Number of Participants With Serum Phosphorus Level Abnormalities | Normal serum phosphorus range was 2.7-4.6 mg/dL. | All participants. n=number of participants with evaluable data at given time-point | Posted | | Number | | participants | | Baseline, Enrollment Visit, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Participants Within the Phosphorus Normal Range | Normal serum phosphorus range was 2.7-4.6 mg/dL. | | OG001 | Participants Outside of the Phosphorus Normal Range | Normal serum phosphorus range was 2.7-4.6 mg/dL. |
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| Secondary | 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. | Number of participants with evaluable data at both Baseline and Visit 3 (6 Months Post-Enrollment) | Posted | | Number | | participants | | Baseline, Month 6 | | | | ID | Title | Description |
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| OG000 | No Albuminuria at Month 6 | The value "-" is taken directly from the dipstick measurements, and represents a reading of no albuminuria. | | OG001 | Trace Albuminuria at Month 6 | The value "Trace" is taken directly from the dipstick measurements, and represents a reading of trace albuminuria. | | OG002 | "+" Albuminuria at Month 6 | The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria. | | OG003 | "++" Albuminuria at Month 6 | |
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| Secondary | 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. | Number of participants with evaluable data at both Baseline and Visit 5 (12 Months Post-Enrollment) | Posted | | Number | | participants | | Baseline, Month 12 | | | | ID | Title | Description |
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| OG000 | No Albuminuria at Month 12 | The value "-" is taken directly from the dipstick measurements, and represents a reading of no albuminuria. | | OG001 | Trace Albuminuria at Month 12 | The value "Trace" is taken directly from the dipstick measurements, and represents a reading of trace albuminuria. | | OG002 | "+" Albuminuria at Month 12 | The value "+" is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria. | | OG003 | "++" Albuminuria at Month 12 | |
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| Secondary | Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study | The HbA1c normal range was 4.3-6.1%. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | percent | | Baseline, Enrollment Visit, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | 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. | | Posted | | Number | | participants | | 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. | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | 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. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Number | | participants | | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | | | | ID | Title | Description |
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| OG000 | CKD Stage 2 | Participants with chronic kidney disease stage 2 (eGFR 60-89 mL/min/1.73m^2) with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) | | OG001 | CKD Stage 3 | Participants with chronic kidney disease stage 3 (eGFR 30-59 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) | | OG002 | CKD Stage 4 | |
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| Secondary | Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | The eGFR normal range was 90-120 mL/min/1.73m^2. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 | The alanine aminotransferase normal range was 11-43 IU/L. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | IU/L | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 | The aspartate aminotransferase normal range was 11-38 IU/L. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | IU/L | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Baseline in Creatinine Levels at Months 6 and 12 | The creatinine normal range was 0.6-1.4 mg/dL. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Baseline in Urea Levels at Months 6 and 12 | The urea normal range was 10-50 mg/dL. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 | The alkaline phosphatase normal range was 40-129 IU/L. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | IU/L | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 | The total cholesterol normal range was 130-200 mg/dL. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mg/dL | | Enrollment, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Enrollment in Triglyceride Levels at Months 6 and 12 | The normal range for triglycerides was 0-200 mg/dL. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mg/dL | | Enrollment, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | 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. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mg/dL | | Enrollment, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | 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. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mg/dL | | Enrollment, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 | The CRP normal range was 0-0.6 mg/dL. | All participants. n=number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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| Secondary | Homocysteine Values Throughout the Study | The homocysteine normal range 3.5-20 μmol/L. | All participants. n=the number of participants with evaluable data at given time-points. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline, Enrollment Visit, Month 6, Month 12 | | | | ID | Title | Description |
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| OG000 | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC) |
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