End-Stage Renal Disease, Secondary Hyperparathyroidism
Conditions
Keywords
Evaluating incidence of hypercalcemia in pediatric patients
Brief summary
The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).
Detailed description
Investigators were free to determine the appropriate therapy for each participant based on clinical judgment. Decisions to prescribe paricalcitol or calcitriol were made independently prior to enrollment of participants in this observational study.
Interventions
DRUGParicalcitol
DRUGCalcitriol
Sponsors
North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days. 2. The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level. 3. The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry. 4. Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures. 5. Patient has received paricalcitol or calcitriol for a minimum of 10 days.
Exclusion criteria
1. Patient is scheduled for a kidney transplant within 3 months. 2. Patient is expected to stop peritoneal dialysis within 3 months. 3. Patient is expected to transfer to hemodialysis within 3 months. 4. Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Incidence of Hypercalcemia | Monitored from time of informed consent through end of study + 30 days (total of 745 days). | Hypercalcemia was defined as calcium \>10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) | Normal ranges for these chemistry measurements varied according to the age of the participant. |
| Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) | Normal ranges for these chemistry measurements varied according to the age of the participant. |
| Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV) | Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) | Normal ranges for these chemistry measurements varied according to the age of the participant. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Monitored from time of informed consent through end of study + 30 days (total of 745 days). | AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record. |
| Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV) | Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) | Normal ranges for these chemistry measurements varied according to the age of the participant. |
| Mean Baseline and Change From Baseline in Albumin at Final Visit (FV) | Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) | Normal ranges for these chemistry measurements varied according to the age of the participant. |
| Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV) | Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) | Normal ranges for these chemistry measurements varied according to the age of the participant. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paricalcitol Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician. | 21 |
| Calcitriol Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician. | 40 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Other Reason | 8 | 17 |
Baseline characteristics
| Characteristic | Paricalcitol | Calcitriol | Total |
|---|---|---|---|
| Age, Customized <8 years | 5 participants | 19 participants | 24 participants |
| Age, Customized >=8 years | 16 participants | 21 participants | 37 participants |
| Region of Enrollment United States | 21 participants | 40 participants | 61 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 19 Participants |
| Sex: Female, Male Male | 14 Participants | 28 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 15 / 21 | 29 / 40 |
| serious Total, serious adverse events | 8 / 21 | 26 / 40 |
Outcome results
Primary
Percentage of Participants With at Least One Incidence of Hypercalcemia
Hypercalcemia was defined as calcium \>10.2 mg/dL. Percentage of participants with hypercalcemia is presented for the overall population, the subgroup of participants in the study for less than 3 months, and those in the study for greater than or equal to 3 months.
Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol | Percentage of Participants With at Least One Incidence of Hypercalcemia | Overall population (n=19, 37) | 36.8 percentage of participants |
| Paricalcitol | Percentage of Participants With at Least One Incidence of Hypercalcemia | Participants <3 months in study (n=2, 5) | 50.0 percentage of participants |
| Paricalcitol | Percentage of Participants With at Least One Incidence of Hypercalcemia | Participants >=3 months in study (n=17, 32) | 35.3 percentage of participants |
| Calcitriol | Percentage of Participants With at Least One Incidence of Hypercalcemia | Overall population (n=19, 37) | 54.1 percentage of participants |
| Calcitriol | Percentage of Participants With at Least One Incidence of Hypercalcemia | Participants <3 months in study (n=2, 5) | 0 percentage of participants |
| Calcitriol | Percentage of Participants With at Least One Incidence of Hypercalcemia | Participants >=3 months in study (n=17, 32) | 62.5 percentage of participants |
Secondary
Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Paricalcitol | Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV) | Baseline | 20.0 pg/mL |
| Paricalcitol | Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV) | Change from Baseline at FV | -10.0 pg/mL |
Secondary
Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Calcitriol | Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV) | Baseline | 28.4 ng/mL | Standard Deviation 6.51 |
| Calcitriol | Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV) | Change from Baseline at FV | 7.5 ng/mL | Standard Deviation 0.78 |
Secondary
Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Baseline and Change From Baseline in Albumin at Final Visit (FV) | Baseline | 3.3 g/dL | Standard Deviation 0.77 |
| Paricalcitol | Mean Baseline and Change From Baseline in Albumin at Final Visit (FV) | Change from Baseline at FV | -0.0 g/dL | Standard Deviation 0.54 |
| Calcitriol | Mean Baseline and Change From Baseline in Albumin at Final Visit (FV) | Baseline | 3.8 g/dL | Standard Deviation 0.52 |
| Calcitriol | Mean Baseline and Change From Baseline in Albumin at Final Visit (FV) | Change from Baseline at FV | -0.1 g/dL | Standard Deviation 0.69 |
Secondary
Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]) with measurements at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV) | Baseline | 571.7 pg/mL | Standard Deviation 532.52 |
| Paricalcitol | Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV) | Change from Baseline at FV | -102.5 pg/mL | Standard Deviation 695.39 |
| Calcitriol | Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV) | Baseline | 592.8 pg/mL | Standard Deviation 619.72 |
| Calcitriol | Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV) | Change from Baseline at FV | -193.4 pg/mL | Standard Deviation 489.11 |
Secondary
Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]); n=number of participants with measurements at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | BUN, BL (n=15, 29) | 52.7 mg/dL | Standard Deviation 24.43 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Calcium, BL (n=15, 30) | 9.2 mg/dL | Standard Deviation 0.84 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | BUN, change from BL at FV (n=15, 29) | -10.7 mg/dL | Standard Deviation 23.18 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Inorganic Phosphate (IP), BL (n=13, 29) | 5.8 mg/dL | Standard Deviation 1.74 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Creatinine, BL (n=15, 29) | 9.4 mg/dL | Standard Deviation 4.35 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Calcium, change from BL at FV (n=15, 30) | 0.0 mg/dL | Standard Deviation 0.77 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Creatinine, change from BL at FV (n=15, 29) | 0.3 mg/dL | Standard Deviation 1.98 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | IP, change from BL at FV (n=13, 29) | -0.4 mg/dL | Standard Deviation 1.55 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Creatinine, change from BL at FV (n=15, 29) | 0.3 mg/dL | Standard Deviation 2.19 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Calcium, BL (n=15, 30) | 9.3 mg/dL | Standard Deviation 1.1 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Calcium, change from BL at FV (n=15, 30) | 0.5 mg/dL | Standard Deviation 1.22 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Inorganic Phosphate (IP), BL (n=13, 29) | 5.9 mg/dL | Standard Deviation 1.71 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | BUN, BL (n=15, 29) | 49.8 mg/dL | Standard Deviation 18.69 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | BUN, change from BL at FV (n=15, 29) | -1.9 mg/dL | Standard Deviation 19.05 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | Creatinine, BL (n=15, 29) | 8.8 mg/dL | Standard Deviation 4.35 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV) | IP, change from BL at FV (n=13, 29) | 0.4 mg/dL | Standard Deviation 1.89 |
Secondary
Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)
Normal ranges for these chemistry measurements varied according to the age of the participant.
Time frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days])
Population: All Treated Population (all participants who received at least 1 dose of paricalcitol \[paricalcitol group\] or at least one dose of calcitriol \[calcitriol group\]); n=number of participants with measurements at baseline and given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Potassium, BL (n=15, 29) | 4.4 mEq/L | Standard Deviation 0.7 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Potassium, change from BL at FV (n=15, 29) | -0.1 mEq/L | Standard Deviation 0.81 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Sodium, BL (n=15, 29) | 138.0 mEq/L | Standard Deviation 2.75 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Sodium, change from BL at FV (n=15, 29) | 0.2 mEq/L | Standard Deviation 2.96 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Chloride, BL (n=15, 29) | 99.5 mEq/L | Standard Deviation 4.75 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Chloride, change from BL at FV (n=15, 29) | -0.5 mEq/L | Standard Deviation 4.52 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Bicarbonate, BL (n=15, 28) | 26.1 mEq/L | Standard Deviation 2.76 |
| Paricalcitol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Bicarbonate, change from BL at FV (n=15, 28) | 0.2 mEq/L | Standard Deviation 3.63 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Bicarbonate, change from BL at FV (n=15, 28) | 0.1 mEq/L | Standard Deviation 4.26 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Potassium, BL (n=15, 29) | 4.4 mEq/L | Standard Deviation 0.83 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Chloride, BL (n=15, 29) | 98.6 mEq/L | Standard Deviation 3.78 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Potassium, change from BL at FV (n=15, 29) | -0.5 mEq/L | Standard Deviation 1 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Bicarbonate, BL (n=15, 28) | 25.9 mEq/L | Standard Deviation 4.12 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Sodium, BL (n=15, 29) | 139.3 mEq/L | Standard Deviation 4.42 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Chloride, change from BL at FV (n=15, 29) | -1.1 mEq/L | Standard Deviation 4.07 |
| Calcitriol | Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV) | Sodium, change from BL at FV (n=15, 29) | -0.7 mEq/L | Standard Deviation 3.43 |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
AE: any untoward medical occurrence that does not necessarily have a causal relationship with treatment; any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered causally related to the use of the product (either paricalcitol or calcitriol); can result from use of the drug as stipulated in the labeling, as well as from accidental or intentional overdose, drug abuse, or drug withdrawal; any worsening of a pre-existing condition or illness. Severity was categorized as mild, moderate, or severe. SAE: AE that results in the death; is life-threatening; results in hospitalization or prolongation of hospitalization; is a congenital anomaly; results in persistent or significant disability/incapacity; is an important medical event requiring medical or surgical intervention to prevent serious outcome; is a spontaneous or elective abortion. For more details, please see the AE section of this record.
Time frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days).
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paricalcitol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any SAE | 8 participants |
| Paricalcitol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any AE leading to discontinuation of study | 0 participants |
| Paricalcitol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any severe AE | 3 participants |
| Paricalcitol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any fatal AE | 0 participants |
| Paricalcitol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any AE leading to discontinuation of study drug | 1 participants |
| Paricalcitol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Deaths (includes non-treatment-emergent deaths) | 0 participants |
| Paricalcitol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any AE | 17 participants |
| Calcitriol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Deaths (includes non-treatment-emergent deaths) | 2 participants |
| Calcitriol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any AE | 32 participants |
| Calcitriol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any severe AE | 12 participants |
| Calcitriol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any SAE | 26 participants |
| Calcitriol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any AE leading to discontinuation of study drug | 3 participants |
| Calcitriol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any AE leading to discontinuation of study | 1 participants |
| Calcitriol | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs | Any fatal AE | 2 participants |