Trial Outcomes & Findings for A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis (NCT NCT01382212)

NCT ID: NCT01382212

Last Updated: 2018-07-02

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 13 participants
• Primary outcome timeframe: Day 1 to Week 12
• Results posted on: 2018-07-02

Participant Flow

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.

Participant milestones

Measure	Paricalcitol Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Paricalcitol Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Study Kidney transplant	1
Overall Study Withdrew consent	1

Baseline Characteristics

A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Baseline characteristics by cohort

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Age, Continuous	14.5 years STANDARD_DEVIATION 1.76 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 to Week 12

Population: All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol

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).

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Percentage of Subjects With Hypercalcemia	15.3 percentage of participants Interval 1.9 to 45.4

SECONDARY outcome

Timeframe: Baseline (last measurement collected prior to the first dose) to Week 12

Population: All-treated data set

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL	38.5 percentage of participants Interval 13.9 to 68.4

SECONDARY outcome

Timeframe: Baseline (last measurement collected prior to the first dose) to Week 12

Population: All-treated data set

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline	61.5 percentage of participants Interval 31.6 to 86.1

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Hemoglobin: Mean Change From Baseline to Final Visit	-0.1 g/dL Standard Deviation 1.263

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Hematocrit: Mean Change From Baseline to Final Visit	-1.08 percent Standard Deviation 5.066

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Red Blood Cells: Mean Change From Baseline to Final Visit	-0.09 cells x 10^6/µL Standard Deviation 0.496

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
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
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

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
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
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
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
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
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 outcome

Timeframe: 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

n=subjects with evaluable Baseline and Post-baseline data for each parameter.

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
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
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
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
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 outcome

Timeframe: 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

n=subjects with evaluable Baseline and Post-baseline data for each parameter.

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
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
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
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
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
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
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
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
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
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
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
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
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
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 outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Alkaline Phosphatase: Mean Change From Baseline to Final Visit	-61.8 IU/L Standard Deviation 117.34

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=11 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit Sodium	-0.5 mEq/L Standard Deviation 2.02
Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit Potassium	0.25 mEq/L Standard Deviation 0.746
Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit Chloride	0.5 mEq/L Standard Deviation 3.21
Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit Bicarbonate	-0.45 mEq/L Standard Deviation 3.446

SECONDARY outcome

Timeframe: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Population: All-treated data set

n=subjects with evaluable Baseline and Post-baseline data for each parameter.

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Total Protein and Albumin: Mean Change From Baseline to Final Visit Total protein (n=11)	0.15 g/dL Standard Deviation 0.43
Total Protein and Albumin: Mean Change From Baseline to Final Visit Albumin (n=13)	0.04 g/dL Standard Deviation 0.325

SECONDARY outcome

Timeframe: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Population: All-treated data set

n=subjects with evaluable Baseline and Post-baseline data for each parameter.

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
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
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
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
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

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Paricalcitol n=10 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Osteocalcin: Mean Change From Baseline to Final Visit	117.21 ng/mL Standard Deviation 223.07

SECONDARY outcome

Timeframe: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).

Population: All-treated data set

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.

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Number of Subjects With Adverse Events Any TEAE	11 participants
Number of Subjects With Adverse Events TESAE	2 participants

SECONDARY outcome

Timeframe: Baseline (Day 1) to Final Visit (up to Week 12)

Population: All-treated data set

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.

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings	0 participants

SECONDARY outcome

Timeframe: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Population: All-treated data set

Blood pressure was measured after the subject had been sitting for at least 3 minutes.

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
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
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

SECONDARY outcome

Timeframe: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Population: All-treated data set

Heart rate was measured after the subject had been sitting for at least 3 minutes.

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Heart Rate: Mean Change From Baseline to Final Visit	1.8 bpm Standard Deviation 17.43

SECONDARY outcome

Timeframe: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)

Population: All-treated data set

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Oral Body Temperature: Mean Change From Baseline to Final Visit	0.03 degrees Celsius Standard Deviation 0.338

SECONDARY outcome

Timeframe: Baseline (Day 1) and Final Visit (up to Week 12)

Population: All-treated data set

Outcome measures

Measure	Paricalcitol n=13 Participants Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Number of Subjects With Potentially Clinically Significant Physical Examination Findings	0 participants

Adverse Events

Paricalcitol

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paricalcitol n=13 participants at risk Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Injury, poisoning and procedural complications PERITONEAL DIALYSIS COMPLICATION	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Metabolism and nutrition disorders FLUID OVERLOAD	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).

Other adverse events

Measure	Paricalcitol n=13 participants at risk Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Gastrointestinal disorders ABDOMINAL PAIN	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Gastrointestinal disorders ABDOMINAL PAIN UPPER	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Gastrointestinal disorders DIARRHOEA	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Gastrointestinal disorders NAUSEA	15.4% 2/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Gastrointestinal disorders VOMITING	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
General disorders INFLUENZA LIKE ILLNESS	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
General disorders PYREXIA	15.4% 2/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE COMPLICATION	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Injury, poisoning and procedural complications PROCEDURAL PAIN	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Injury, poisoning and procedural complications PROCEDURAL VOMITING	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Investigations BLOOD CALCIUM INCREASED	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Investigations HAEMOGLOBIN DECREASED	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Musculoskeletal and connective tissue disorders BACK PAIN	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Nervous system disorders HEADACHE	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Respiratory, thoracic and mediastinal disorders COUGH	15.4% 2/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Skin and subcutaneous tissue disorders PRURITUS	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Vascular disorders HYPERTENSION	7.7% 1/13 • Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).

Additional Information

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