End-Stage Renal Disease, Secondary Hyperparathyroidism
Conditions
Keywords
Evaluate safety through the evaluation of the incidence of hypercalcemia in pediatric subjects
Brief summary
The objective is to evaluate the safety of paricalcitol capsules in pediatric subjects, ages 10 to 16 years old, with Stage 5 chronic kidney disease (kidney failure) receiving peritoneal dialysis or hemodialysis and being treated for secondary hyperparathyroidism. Subjects will be in the dosing period of the study for 12 weeks in order to evaluate the incidence of hypercalcemia (high calcium levels in blood). Approximately 12 subjects will be enrolled and all 12 will receive paricalcitol capsules.
Interventions
DRUGparicalcitol
Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Subject must be receiving peritoneal dialysis or hemodialysis for at least 3 months prior to Screening * Subject is currently being diagnosed and/or treated for secondary hyperparathyroidism * For entry into the Dosing Period (for subjects that are naïve to Vitamin D Receptor \[VDR\] Activators or those who have completed a 2 to 12 week washout), the subject must meet the following laboratory criteria prior to enrollment: * A corrected calcium value ≥ 8.2 and ≤ 10.4 mg/dL * A phosphorus value ≤ 6.5 mg/dL * An intact parathyroid hormone (iPTH) value \> 300 pg/mL and less ≤ 2000 pg/mL
Exclusion criteria
* Subject is expected or scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant patient requiring full immunosuppressant therapy * Subject is expected to stop peritoneal dialysis or hemodialysis within 4 months of Screening (per investigator discretion) * Subject has had a parathyroidectomy within 12 weeks prior to Screening * Subject has had symptomatic or significant hypocalcemia requiring VDR Activator therapy (i.e., calcitriol, paricalcitol, or doxercalciferol) within 2 months prior to Screening * Subject is taking maintenance calcitonin, bisphosphonates, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 to 8 weeks prior to Dosing * Subject is receiving cinacalcet at the time of Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Hypercalcemia | Day 1 to Week 12 | The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \> 10.2 mg/dL (2.55 mmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline | Baseline (last measurement collected prior to the first dose) to Week 12 | — |
| Hemoglobin: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| Hematocrit: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| Red Blood Cells: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | n=subjects with evaluable Baseline and Post-baseline data for each parameter. |
| Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | n=subjects with evaluable Baseline and Post-baseline data for each parameter. |
| Alkaline Phosphatase: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL | Baseline (last measurement collected prior to the first dose) to Week 12 | — |
| Total Protein and Albumin: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | n=subjects with evaluable Baseline and Post-baseline data for each parameter. |
| Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | n=subjects with evaluable Baseline and Post-baseline data for each parameter. |
| Osteocalcin: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| Number of Subjects With Adverse Events | From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks). | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. |
| Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings | Baseline (Day 1) to Final Visit (up to Week 12) | 12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented. |
| Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | Blood pressure was measured after the subject had been sitting for at least 3 minutes. |
| Heart Rate: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | Heart rate was measured after the subject had been sitting for at least 3 minutes. |
| Oral Body Temperature: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
| Number of Subjects With Potentially Clinically Significant Physical Examination Findings | Baseline (Day 1) and Final Visit (up to Week 12) | — |
| Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit | Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) | — |
Participant flow
Pre-assignment details
A total of 26 subjects were screened and 13 pediatric subjects (between 10 and 16 years of age) were enrolled; 1 subject was 16 years of age at the time of Screening and turned 17 by the time treatment began.
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Kidney transplant | 1 |
| Overall Study | Withdrew consent | 1 |
Baseline characteristics
| Characteristic | Paricalcitol |
|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 1.76 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
Percentage of Subjects With Hypercalcemia
The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values \> 10.2 mg/dL (2.55 mmol/L).
Time frame: Day 1 to Week 12
Population: All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol | Percentage of Subjects With Hypercalcemia | 15.3 percentage of participants |
Secondary
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit | ALT (n=11) | -4.55 U/L | Standard Deviation 16.501 |
| Paricalcitol | Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit | AST (n=11) | -4.45 U/L | Standard Deviation 12.25 |
| Paricalcitol | Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit | LDH (n=11) | -6.5 U/L | Standard Deviation 33.22 |
| Paricalcitol | Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit | BSAP (n=9) | -49.4 U/L | Standard Deviation 86.95 |
Secondary
Alkaline Phosphatase: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol | Alkaline Phosphatase: Mean Change From Baseline to Final Visit | -61.8 IU/L | Standard Deviation 117.34 |
Secondary
Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | BUN (n=11) | 1.33 mg/dL | Standard Deviation 11.614 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Uric Acid (n=11) | 0.31 mg/dL | Standard Deviation 1.245 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Magnesium (n=11) | 0.082 mg/dL | Standard Deviation 0.3649 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Glucose (n=11) | 4.36 mg/dL | Standard Deviation 10.172 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Cholesterol (n=11) | -16.4 mg/dL | Standard Deviation 27.37 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Total bilirubin (n=11) | 0.032 mg/dL | Standard Deviation 0.3165 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Direct Bilirubin (n=11) | 0.013 mg/dL | Standard Deviation 0.0785 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Indirect Bilirubin (n=9) | 0.056 mg/dL | Standard Deviation 0.3035 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Triglycerides (n=11) | 9.2 mg/dL | Standard Deviation 40.32 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | hsCRP (n=11) | 0.061 mg/dL | Standard Deviation 0.1967 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Inorganic phosphate (n=13) | 0.64 mg/dL | Standard Deviation 1.188 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Corrected Calcium (n=7) | 0.31 mg/dL | Standard Deviation 0.421 |
| Paricalcitol | Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit | Creatinine (n=11) | 0.48 mg/dL | Standard Deviation 1.592 |
Secondary
Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All-treated data set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit | 25-Hydroxy Vitamin D (n=11) | 5.8 pg/mL | Standard Deviation 10.38 |
| Paricalcitol | Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit | iPTH (n=13) | -437.5 pg/mL | Standard Deviation 491.83 |
| Paricalcitol | Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit | FGF-23 (n=10) | 1990.7 pg/mL | Standard Deviation 3317.7 |
| Paricalcitol | Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit | 1,25-Hydroxy Vitamin D (n=11) | 15.65 pg/mL | Standard Deviation 29.296 |
Secondary
Heart Rate: Mean Change From Baseline to Final Visit
Heart rate was measured after the subject had been sitting for at least 3 minutes.
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All-treated data set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol | Heart Rate: Mean Change From Baseline to Final Visit | 1.8 bpm | Standard Deviation 17.43 |
Secondary
Hematocrit: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol | Hematocrit: Mean Change From Baseline to Final Visit | -1.08 percent | Standard Deviation 5.066 |
Secondary
Hemoglobin: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol | Hemoglobin: Mean Change From Baseline to Final Visit | -0.1 g/dL | Standard Deviation 1.263 |
Secondary
Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | Neutrophils | 0.11 cells x 10^9/µL | Standard Deviation 2.6812 |
| Paricalcitol | Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | Lymphocytes | -0.294 cells x 10^9/µL | Standard Deviation 0.597 |
| Paricalcitol | Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | Monocytes | 0.032 cells x 10^9/µL | Standard Deviation 0.1276 |
| Paricalcitol | Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | Eosinophils | 0.059 cells x 10^9/µL | Standard Deviation 0.1522 |
| Paricalcitol | Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit | Basophils | -0.01 cells x 10^9/µL | Standard Deviation 0.0322 |
Secondary
Number of Subjects With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Time frame: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).
Population: All-treated data set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol | Number of Subjects With Adverse Events | Any TEAE | 11 participants |
| Paricalcitol | Number of Subjects With Adverse Events | TESAE | 2 participants |
Secondary
Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings
12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.
Time frame: Baseline (Day 1) to Final Visit (up to Week 12)
Population: All-treated data set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol | Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings | 0 participants |
Secondary
Number of Subjects With Potentially Clinically Significant Physical Examination Findings
Time frame: Baseline (Day 1) and Final Visit (up to Week 12)
Population: All-treated data set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol | Number of Subjects With Potentially Clinically Significant Physical Examination Findings | 0 participants |
Secondary
Oral Body Temperature: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All-treated data set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol | Oral Body Temperature: Mean Change From Baseline to Final Visit | 0.03 degrees Celsius | Standard Deviation 0.338 |
Secondary
Osteocalcin: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol | Osteocalcin: Mean Change From Baseline to Final Visit | 117.21 ng/mL | Standard Deviation 223.07 |
Secondary
Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL
Time frame: Baseline (last measurement collected prior to the first dose) to Week 12
Population: All-treated data set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol | Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL | 38.5 percentage of participants |
Secondary
Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline
Time frame: Baseline (last measurement collected prior to the first dose) to Week 12
Population: All-treated data set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paricalcitol | Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline | 61.5 percentage of participants |
Secondary
Red Blood Cells: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paricalcitol | Red Blood Cells: Mean Change From Baseline to Final Visit | -0.09 cells x 10^6/µL | Standard Deviation 0.496 |
Secondary
Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit | Sodium | -0.5 mEq/L | Standard Deviation 2.02 |
| Paricalcitol | Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit | Potassium | 0.25 mEq/L | Standard Deviation 0.746 |
| Paricalcitol | Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit | Chloride | 0.5 mEq/L | Standard Deviation 3.21 |
| Paricalcitol | Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit | Bicarbonate | -0.45 mEq/L | Standard Deviation 3.446 |
Secondary
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit
Blood pressure was measured after the subject had been sitting for at least 3 minutes.
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All-treated data set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit | DBP | 3.7 mm Hg | Standard Deviation 12.98 |
| Paricalcitol | Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit | SBP | 7.5 mm Hg | Standard Deviation 15.66 |
Secondary
Total Protein and Albumin: Mean Change From Baseline to Final Visit
n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All-treated data set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Total Protein and Albumin: Mean Change From Baseline to Final Visit | Total protein (n=11) | 0.15 g/dL | Standard Deviation 0.43 |
| Paricalcitol | Total Protein and Albumin: Mean Change From Baseline to Final Visit | Albumin (n=13) | 0.04 g/dL | Standard Deviation 0.325 |
Secondary
White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit
Time frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Population: All subjects in the all-treated data set with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit | WBC | -0.06 cells x 10^3/µL | Standard Deviation 2.982 |
| Paricalcitol | White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit | Platelet Count | 19.2 cells x 10^3/µL | Standard Deviation 47.03 |