Chronic Kidney Failure, Secondary Hyperparathyroidism
Conditions
Keywords
Secondary Hyperparathyroidism, Chronic Kidney Failure
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with secondary hyperparathyroidism in the presence of chronic kidney disease stage 3, 4 or 5 treated with Zemplar (paricalcitol) oral for at least 1 month prior to study enrollment * Male and female (not pregnant or not planning to be pregnant in the next 12 months) patients \> 18 years of age * Signed informed consent by subject * Hypertensive and diabetic subjects must be on an optimal and steady medication regimen for more than 30 days
Exclusion criteria
* Contraindications listed in the Summary of Product Characteristics for Zemplar capsules apply (Appendix I and II) * Parathormone value of \> 1000 pg/mL (sign of tertiary hyperparathyroidism) * Treatment with Vitamin D within the last 1 month prior to inclusion into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | 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. |
| Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | 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. |
| Number of Participants With Serum Calcium Level Abnormalities | Baseline, Enrollment Visit, Month 6, Month 12 | Normal serum calcium range was 8.4-10.2 mg/dL. |
| Number of Participants With Serum Phosphorus Level Abnormalities | Baseline, Enrollment Visit, Month 6, Month 12 | Normal serum phosphorus range was 2.7-4.6 mg/dL. |
| Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Baseline, 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. |
| Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Baseline, 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. |
| Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study | Baseline, Enrollment Visit, Month 6, Month 12 | The HbA1c normal range was 4.3-6.1%. |
| Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) | 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. | 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. |
| Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | 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. |
| Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12 | The eGFR normal range was 90-120 mL/min/1.73m\^2. |
| Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 | Baseline, Month 6, Month 12 | The alanine aminotransferase normal range was 11-43 IU/L. |
| Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels | Measured from start of study, up to a maximum of 12 months | 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). |
| Change From Baseline in Creatinine Levels at Months 6 and 12 | Baseline, Month 6, Month 12 | The creatinine normal range was 0.6-1.4 mg/dL. |
| Change From Baseline in Urea Levels at Months 6 and 12 | Baseline, Month 6, Month 12 | The urea normal range was 10-50 mg/dL. |
| Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 | Baseline, Month 6, Month 12 | The alkaline phosphatase normal range was 40-129 IU/L. |
| Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 | Enrollment, Month 6, Month 12 | The total cholesterol normal range was 130-200 mg/dL. |
| Change From Enrollment in Triglyceride Levels at Months 6 and 12 | Enrollment, Month 6, Month 12 | The normal range for triglycerides was 0-200 mg/dL. |
| Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 | Enrollment, Month 6, Month 12 | The LDL-C normal range was 0-150 mg/dL. |
| Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 | Enrollment, Month 6, Month 12 | The HDL-C normal range was 35-90 mg/dL. |
| Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 | Baseline, Month 6, Month 12 | The CRP normal range was 0-0.6 mg/dL. |
| Homocysteine Values Throughout the Study | Baseline, Enrollment Visit, Month 6, Month 12 | The homocysteine normal range 3.5-20 μmol/L. |
| Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 | Baseline, Month 6, Month 12 | The aspartate aminotransferase normal range was 11-38 IU/L. |
| Mean Duration of Effect Sustainability (Months) | Measured from start of study, up to a maximum of 12 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. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 500 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Reasons | 2 |
| Overall Study | Adverse Event | 3 |
| Overall Study | Consent Withdrawal | 7 |
| Overall Study | Death | 3 |
| Overall Study | Hemodialysis Initiation | 28 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 48 |
| Overall Study | Non-compliance to Study Treatment | 1 |
Baseline characteristics
| Characteristic | Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism |
|---|---|
| Age Continuous | 67.4 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 186 Participants |
| Sex: Female, Male Male | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 168 / 500 |
| serious Total, serious adverse events | 19 / 500 |
Outcome results
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.
Time frame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Population: Overall study population. n=number of participants with available data at given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Before Study Treatment (Baseline); n=495 | 232.1 pg/mL | Standard Deviation 168.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Visit 1 (Enrollment); n=497 | 200.1 pg/mL | Standard Deviation 141.1 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Visit 2 (3 Months Post-Enrollment); n=432 | 166.6 pg/mL | Standard Deviation 137.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Visit 3 (6 Months Post-Enrollment); n=405 | 157.3 pg/mL | Standard Deviation 172.9 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Visit 4 (9 Months Post-Enrollment); n=378 | 135.2 pg/mL | Standard Deviation 99.5 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Visit 5 (12 Months Post-Enrollment); n=368 | 119.4 pg/mL | Standard Deviation 63.1 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Baseline to Enrollment; n=492 | -32.2 pg/mL | Standard Deviation 96 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Baseline to Visit 2; n=429 | -62.6 pg/mL | Standard Deviation 125.5 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Baseline to Visit 3; n=402 | -69.7 pg/mL | Standard Deviation 172.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Baseline to Visit 4; n=376 | -85.4 pg/mL | Standard Deviation 129.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Baseline to Visit 5; n=364 | -96.1 pg/mL | Standard Deviation 130.8 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Enrollment to Visit 2; n=430 | -35.6 pg/mL | Standard Deviation 93.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Enrollment to Visit 3; n=404 | -41.9 pg/mL | Standard Deviation 150.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Enrollment to Visit 4; n=378 | -58.4 pg/mL | Standard Deviation 112.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Overall Study Population | Change from Enrollment to Visit 5; n=367 | -72.4 pg/mL | Standard Deviation 113.4 |
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.
Time frame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Population: Participants with renal transplantation history. n=number of participants with available data at given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Baseline to Visit 3; n=21 | -95.4 pg/mL | Standard Deviation 262 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Before Study Treatment (Baseline); n=40 | 321.5 pg/mL | Standard Deviation 293.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Visit 1 (Enrollment); n=39 | 269.3 pg/mL | Standard Deviation 214.5 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Visit 2 (3 Months Post-Enrollment); n=27 | 240.1 pg/mL | Standard Deviation 166 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Visit 3 (6 Months Post-Enrollment); n=21 | 271.4 pg/mL | Standard Deviation 225.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Visit 4 (9 Months Post-Enrollment); n=15 | 299.7 pg/mL | Standard Deviation 231.9 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Visit 5 (12 Months Post-Enrollment); n=21 | 182.9 pg/mL | Standard Deviation 109.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Baseline to Enrollment; n=39 | -50.1 pg/mL | Standard Deviation 144.8 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Baseline to Visit 2; n=27 | -93.0 pg/mL | Standard Deviation 134.8 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Baseline to Visit 4; n=15 | -71.3 pg/mL | Standard Deviation 228.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Baseline to Visit 5; n=21 | -92.5 pg/mL | Standard Deviation 139.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Enrollment to Visit 2; n=26 | -61.3 pg/mL | Standard Deviation 106.1 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Enrollment to Visit 3; n=20 | -72.1 pg/mL | Standard Deviation 215 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Enrollment to Visit 4; n=15 | -69.0 pg/mL | Standard Deviation 207.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Intact Parathormone (iPTH) Changes During the Study Time-Points for Subpopulation of Renal Transplanted Participants | Change from Enrollment to Visit 5; n=20 | -73.1 pg/mL | Standard Deviation 144.6 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 | Before Study Treatment (Baseline); n=367 | 20.2 IU/L | Standard Deviation 10.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=276 | -0.4 IU/L | Standard Deviation 11 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Alanine Aminotransferase (ALT) Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 months); n=259 | 0.3 IU/L | Standard Deviation 11.3 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 | Before Study Treatment (Baseline); n=329 | 124.0 IU/L | Standard Deviation 73.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=245 | -5.0 IU/L | Standard Deviation 49.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Alkaline Phosphatase (ALP) Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 months); n=215 | -10.3 IU/L | Standard Deviation 62.4 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 | Before Study Treatment (Baseline); n=365 | 21.1 IU/L | Standard Deviation 10.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=276 | 0.0 IU/L | Standard Deviation 10.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Aspartate Aminotransferase (AST) Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 months); n=257 | -0.9 IU/L | Standard Deviation 10.8 |
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.
Time frame: Baseline, Month 6, Month 12
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 | Before Study Treatment (Baseline); n=149 | 1.9 mg/dL | Standard Deviation 3.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=110 | -0.8 mg/dL | Standard Deviation 2.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in C-Reactive Protein (CRP) Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 Months); n=101 | 0.5 mg/dL | Standard Deviation 4.5 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Creatinine Levels at Months 6 and 12 | Before Study Treatment (Baseline); n=499 | 2.4 mg/dL | Standard Deviation 0.9 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Creatinine Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=450 | 0.2 mg/dL | Standard Deviation 0.8 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Creatinine Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 months); n=406 | 0.4 mg/dL | Standard Deviation 0.9 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Urea Levels at Months 6 and 12 | Before Study Treatment (Baseline); n=494 | 99.0 mg/dL | Standard Deviation 40.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Urea Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=443 | 2.2 mg/dL | Standard Deviation 32.1 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Baseline in Urea Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 months); n=399 | 7.2 mg/dL | Standard Deviation 35.3 |
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.
Time frame: Enrollment, Month 6, Month 12
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 | Enrollment (Visit 1); n=271 | 49.8 mg/dL | Standard Deviation 16.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=193 | -1.1 mg/dL | Standard Deviation 18.7 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in High Density Lipoprotein Cholesterol (HDL-C) Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 Months); n=166 | -0.7 mg/dL | Standard Deviation 20.2 |
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.
Time frame: Enrollment, Month 6, Month 12
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 | Visit 1 (Enrollment); n=234 | 106.8 mg/dL | Standard Deviation 42.8 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=144 | -1.6 mg/dL | Standard Deviation 36.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Low Density Lipoprotein Cholesterol (LDL-C) Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 months); n=123 | 0.1 mg/dL | Standard Deviation 48.3 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 | Visit 1 (Enrollment); n=367 | 186.3 mg/dL | Standard Deviation 43.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 | Change from Enrollment to Visit 3 (6 Months);n=272 | -3.8 mg/dL | Standard Deviation 38.1 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Total Cholesterol Levels at Months 6 and 12 | Change from Enrollment to Visit 5(12 months);n=243 | -5.4 mg/dL | Standard Deviation 39.6 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Triglyceride Levels at Months 6 and 12 | Visit 1 (Enrollment); n=353 | 151.0 mg/dL | Standard Deviation 80.5 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Triglyceride Levels at Months 6 and 12 | Change from Baseline to Visit 3 (6 Months); n=259 | -10.2 mg/dL | Standard Deviation 56 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change From Enrollment in Triglyceride Levels at Months 6 and 12 | Change from Baseline to Visit 5 (12 months); n=228 | -10.3 mg/dL | Standard Deviation 64.5 |
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.
Time frame: Baseline, Month 12
Population: Number of participants with evaluable data at both Baseline and Visit 5 (12 Months Post-Enrollment)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade ++ at Baseline | 2 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade - at Baseline | 18 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade +++ at Baseline | 0 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade Trace at Baseline | 0 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade + at Baseline | 14 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade ++ at Baseline | 0 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade + at Baseline | 1 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade Trace at Baseline | 0 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade +++ at Baseline | 0 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade - at Baseline | 3 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade + at Baseline | 37 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade - at Baseline | 6 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade Trace at Baseline | 1 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade ++ at Baseline | 8 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade +++ at Baseline | 6 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade +++ at Baseline | 1 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade - at Baseline | 3 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade ++ at Baseline | 13 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade + at Baseline | 9 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade Trace at Baseline | 0 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade + at Baseline | 2 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade ++ at Baseline | 5 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade - at Baseline | 0 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade +++ at Baseline | 20 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 12 | Grade Trace at Baseline | 0 participants |
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.
Time frame: Baseline, Month 6
Population: Number of participants with evaluable data at both Baseline and Visit 3 (6 Months Post-Enrollment)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade - at Baseline | 19 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade ++ at Baseline | 2 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade Trace at Baseline | 1 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade + at Baseline | 15 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade +++ at Baseline | 0 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade - at Baseline | 1 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade ++ at Baseline | 0 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade +++ at Baseline | 2 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade Trace at Baseline | 0 participants |
| Participants Out of the iPTH Target Range | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade + at Baseline | 1 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade +++ at Baseline | 7 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade - at Baseline | 10 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade ++ at Baseline | 9 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade + at Baseline | 36 participants |
| + Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade Trace at Baseline | 1 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade ++ at Baseline | 18 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade - at Baseline | 2 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade Trace at Baseline | 0 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade + at Baseline | 10 participants |
| ++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade +++ at Baseline | 6 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade Trace at Baseline | 0 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade - at Baseline | 0 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade ++ at Baseline | 4 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade +++ at Baseline | 15 participants |
| +++ Albuminuria at Month 6 | Change in Dipstick Albuminuria Grade From Baseline to Month 6 | Grade + at Baseline | 3 participants |
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.
Time frame: Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Population: All participants. n=participants with evaluable data at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 2 (3 Months Post-Enrollment); n=432 | 75 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 4 (9 Months Post-Enrollment); n=378 | 89 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 3 (6 Months Post-Enrollment); n=405 | 76 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 5 (12 Months Post-Enrollment); n=368 | 101 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 1 (Enrollment); n=497 | 11 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 5 (12 Months Post-Enrollment); n=368 | 267 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 1 (Enrollment); n=497 | 486 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 2 (3 Months Post-Enrollment); n=432 | 357 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 3 (6 Months Post-Enrollment); n=405 | 329 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Achievement of Intact Parathormone (iPTH) Levels Within the Target Range | Visit 4 (9 Months Post-Enrollment); n=378 | 289 participants |
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.
Time frame: Baseline, Enrollment Visit, Month 3, Month 6, Month 9, Month 12
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 4 (9 Months Post-Enrollment); n=426 | 3 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 2 (3 Months Post-Enrollment); n=463 | 2 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 5 (12 Months Post-Enrollment); n=406 | 1 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 3 (6 Months Post-Enrollment); n=451 | 3 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 1 (Enrollment); n=500 | 0 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 3 (6 Months Post-Enrollment); n=451 | 197 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 4 (9 Months Post-Enrollment); n=426 | 190 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 5 (12 Months Post-Enrollment); n=406 | 175 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 2 (3 Months Post-Enrollment); n=463 | 214 participants |
| Participants Out of the iPTH Target Range | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 1 (Enrollment); n=500 | 234 participants |
| + Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 3 (6 Months Post-Enrollment); n=451 | 210 participants |
| + Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 1 (Enrollment); n=500 | 266 participants |
| + Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 2 (3 Months Post-Enrollment); n=463 | 214 participants |
| + Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 4 (9 Months Post-Enrollment); n=426 | 185 participants |
| + Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 5 (12 Months Post-Enrollment); n=406 | 184 participants |
| ++ Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 4 (9 Months Post-Enrollment); n=426 | 48 participants |
| ++ Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 2 (3 Months Post-Enrollment); n=463 | 33 participants |
| ++ Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 1 (Enrollment); n=500 | 0 participants |
| ++ Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 3 (6 Months Post-Enrollment); n=451 | 41 participants |
| ++ Albuminuria at Month 6 | Distribution of Participants by Chronic Kidney Disease (CKD) Stage Throughout Study | Visit 5 (12 Months Post-Enrollment); n=406 | 46 participants |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | Before Study Treatment (Baseline); n=499 | 30.4 mL/min/1.73m^2 | Standard Deviation 11.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | Visit 1 (Enrollment); n=500 | 29.9 mL/min/1.73m^2 | Standard Deviation 11.3 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | Visit 2 (3 Months Post-Enrollment); n=463 | 29.6 mL/min/1.73m^2 | Standard Deviation 12.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | Visit 3 (6 Months Post-Enrollment); n=451 | 29.6 mL/min/1.73m^2 | Standard Deviation 12.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | Visit 4 (9 Months Post-Enrollment); n=426 | 29.6 mL/min/1.73m^2 | Standard Deviation 12.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Estimated Glomerular Filtration Rate (eGFR) Values Throughout the Study | Visit 5 (12 Months Post-Enrollment); n=406 | 29.1 mL/min/1.73m^2 | Standard Deviation 12.4 |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study | Before Study Treatment (Baseline); n=101 | 7.2 percent | Standard Deviation 1.6 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study | Visit 1 (Enrollment); n=99 | 6.9 percent | Standard Deviation 1.4 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study | Visit 3 (6 Months Post-Enrollment); n=76 | 7.0 percent | Standard Deviation 1.5 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Glycosylated Hemoglobin A1c (HbA1c) Values Throughout the Study | Visit 5 (12 Months Post-Enrollment); n=69 | 6.9 percent | Standard Deviation 1.2 |
Secondary
Homocysteine Values Throughout the Study
The homocysteine normal range 3.5-20 μmol/L.
Time frame: Baseline, Enrollment Visit, Month 6, Month 12
Population: All participants. n=the number of participants with evaluable data at given time-points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Homocysteine Values Throughout the Study | Visit 1 (Enrollment); n=52 | 24.3 μmol/L | Standard Deviation 9.5 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Homocysteine Values Throughout the Study | Before Study Treatment (Baseline); n=16 | 24.8 μmol/L | Standard Deviation 6.9 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Homocysteine Values Throughout the Study | Visit 2 (3 Months Post-Enrollment); n=35 | 23.2 μmol/L | Standard Deviation 7.5 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Homocysteine Values Throughout the Study | Visit 3 (6 Months Post-Enrollment); n=15 | 23.4 μmol/L | Standard Deviation 8.2 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Homocysteine Values Throughout the Study | Visit 4 (9 Months Post-Enrollment); n=17 | 24.7 μmol/L | Standard Deviation 8 |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Homocysteine Values Throughout the Study | Visit 5 (12 Months Post-Enrollment); n=13 | 22.4 μmol/L | Standard Deviation 10.1 |
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.
Time frame: Measured from start of study, up to a maximum of 12 months
Population: All evaluable participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Mean Duration of Effect Sustainability (Months) | 3.8 months | Standard Deviation 2.4 |
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).
Time frame: Measured from start of study, up to a maximum of 12 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Median Time to Attain the First Lower Intact Parathormone (iPTH) Levels | 7.8 months |
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.
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.
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) | Adverse Events (nSAEs and SAEs) | 192 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) | nSAEs | 180 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Non-serious Adverse Events (nSAEs) and Serious Adverse Events (SAEs) | SAEs | 19 participants |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Calcium Level Abnormalities | Before Study Treatment (Baseline); n=461 | 384 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Calcium Level Abnormalities | Visit 1 (Enrollment); n=471 | 409 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Calcium Level Abnormalities | Visit 3 (6 Months Post-Enrollment); n=436 | 391 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Calcium Level Abnormalities | Visit 5 (12 Months Post-Enrollment); n=386 | 342 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Calcium Level Abnormalities | Visit 5 (12 Months Post-Enrollment); n=386 | 44 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Calcium Level Abnormalities | Before Study Treatment (Baseline); n=461 | 77 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Calcium Level Abnormalities | Visit 3 (6 Months Post-Enrollment); n=436 | 45 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Calcium Level Abnormalities | Visit 1 (Enrollment); n=471 | 62 participants |
Secondary
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
Population: All participants. n=number of participants with evaluable data at given time-point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Phosphorus Level Abnormalities | Before Study Treatment (Baseline); n=451 | 367 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Phosphorus Level Abnormalities | Visit 1 (Enrollment); n=466 | 361 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Phosphorus Level Abnormalities | Visit 3 (6 Months Post-Enrollment); n=429 | 326 participants |
| Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism | Number of Participants With Serum Phosphorus Level Abnormalities | Visit 5 (12 Months Post-Enrollment); n=375 | 271 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Phosphorus Level Abnormalities | Visit 5 (12 Months Post-Enrollment); n=375 | 104 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Phosphorus Level Abnormalities | Before Study Treatment (Baseline); n=451 | 84 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Phosphorus Level Abnormalities | Visit 3 (6 Months Post-Enrollment); n=429 | 103 participants |
| Participants Out of the iPTH Target Range | Number of Participants With Serum Phosphorus Level Abnormalities | Visit 1 (Enrollment); n=466 | 105 participants |