Trial Outcomes & Findings for A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia (NCT NCT02688764)

NCT ID: NCT02688764

Last Updated: 2019-09-10

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

85 participants

Primary outcome timeframe

From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Results posted on

2019-09-10

Participant Flow

Participant milestones

Participant milestones
Measure	PA21 (Velphoro®) Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.	Calcium Acetate (Phoslyra®) Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Overall Study STARTED	66	19
Overall Study Treated in Stage 1	66	19
Overall Study Treated in Stage 2	43	8
Overall Study COMPLETED	26	2
Overall Study NOT COMPLETED	40	17

Reasons for withdrawal

Reasons for withdrawal
Measure	PA21 (Velphoro®) Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.	Calcium Acetate (Phoslyra®) Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Overall Study Adverse Event	3	3
Overall Study AE/Kidney transplant	1	0
Overall Study AE/Lack of efficacy	1	0
Overall Study AE/Non-compl.	1	0
Overall Study AE/Non-compl./Withd. parent	0	1
Overall Study AE/Other	0	1
Overall Study AE/Physician decision	1	0
Overall Study AE/Withd. parent	3	0
Overall Study AE/Withd. parent/Withd. subject	1	1
Overall Study AE/Withd. subject	1	0
Overall Study Kidney transplant	10	4
Overall Study Lack of Efficacy	3	2
Overall Study Lack of efficacy/Physician decision	0	1
Overall Study Non-compliance with study drug	4	0
Overall Study Non-compl./Physician decision	2	0
Overall Study Non-compl./Ph. decision/Withd. subject	1	1
Overall Study Non-compl./Withd. subject	0	2
Overall Study Phosphorus level outside safe range	0	1
Overall Study Phosphorus >7 mg/dL - Withd. by sponsor	1	0
Overall Study Study drug taste/Withd. parent	1	0
Overall Study Subject moving out	2	0
Overall Study Subject taken off dialysis	1	0
Overall Study Withdrawal by parent	3	0

Baseline Characteristics

A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Total n=85 Participants Total of all reporting groups
Region of Enrollment Poland	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Germany	5 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Russia	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Romania	8 participants n=5 Participants	1 participants n=7 Participants	9 participants n=5 Participants
Height	142.3 cm STANDARD_DEVIATION 24.10 • n=5 Participants	140.3 cm STANDARD_DEVIATION 24.12 • n=7 Participants	141.9 cm STANDARD_DEVIATION 23.98 • n=5 Participants
Weight	41.90 kg STANDARD_DEVIATION 18.023 • n=5 Participants	38.28 kg STANDARD_DEVIATION 17.834 • n=7 Participants	41.10 kg STANDARD_DEVIATION 17.939 • n=5 Participants
Age, Continuous	12.2 years STANDARD_DEVIATION 4.07 • n=5 Participants	12.6 years STANDARD_DEVIATION 3.73 • n=7 Participants	12.3 years STANDARD_DEVIATION 3.98 • n=5 Participants
Age, Customized Age, Categorical · Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Age, Categorical · Infants (28 days-23 months)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Age, Categorical · Children (2-11 years)	23 Participants n=5 Participants	6 Participants n=7 Participants	29 Participants n=5 Participants
Age, Customized Age, Categorical · Adolescents (12-17 years)	42 Participants n=5 Participants	13 Participants n=7 Participants	55 Participants n=5 Participants
Age, Customized Age, Categorical · Adults (18-64 years)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	13 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	6 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	5 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	14 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Mass Index	19.621 kg/m^2 STANDARD_DEVIATION 4.6182 • n=5 Participants	18.483 kg/m^2 STANDARD_DEVIATION 4.4238 • n=7 Participants	19.366 kg/m^2 STANDARD_DEVIATION 4.5743 • n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	14 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	2 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	14 participants n=7 Participants	53 participants n=5 Participants
Region of Enrollment France	6 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Lithuania	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Population: Full Analysis Set (FAS) Population: all participants randomised to treatment at Stage 1 who received at least 1 dose of randomised treatment and who had at least 1 post-baseline assessment of the efficacy endpoint (serum phosphorus level), analysed according to treatment randomised.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=65 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group	-0.120 mmol/L Standard Error 0.081	—

PRIMARY outcome

Timeframe: through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Any adverse event Leading to Study Drug Withdrawal is considered.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events	12 Participants	6 Participants

PRIMARY outcome

Timeframe: through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participants, in particular, the number of participants with at least one TEAEs until end of stage 2. Please refer to the detailed tables included on the Adverse Event Module for specifics.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Number and Percentage of Participants With Any Treatment Emergent Adverse Event	50 Participants	14 Participants

SECONDARY outcome

Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=15 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group	-0.615 mmol/L Standard Error 0.320	—

SECONDARY outcome

Timeframe: From baseline to study completion, up to 34 weeks after treatment start date

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=36 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=6 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups	0.099 mmol/L Standard Error 0.198	-0.393 mmol/L Standard Error 0.218

SECONDARY outcome

Timeframe: through study completion, up to 34 weeks after treatment start date

Number and percentages of participants with serum phosphorus levels below, within and above age-dependent target ranges at baseline, at the end of Stage 1 and at the end of Stage 2. The age target ranges for serum phosphorus levels are: * 0 to \<1 year 1.62-2.52 mmol/L * 1 year to \<6 years 1.45-2.10 mmol/L * 6 years to \<13 years 1.16-1.87 mmol/L * 13 years to ≤18 years 0.74-1.45 mmol/L

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=65 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=15 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage Baseline · Below	2 Participants	1 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage Baseline · Within	11 Participants	1 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage Baseline · Above	52 Participants	13 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage End of Stage 1 · Below	2 Participants	1 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage End of Stage 1 · Within	25 Participants	2 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage End of Stage 1 · Above	37 Participants	12 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage End of Stage 2 · Below	1 Participants	0 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage End of Stage 2 · Within	14 Participants	2 Participants
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage End of Stage 2 · Above	25 Participants	6 Participants

SECONDARY outcome

Timeframe: through study completion, up to 34 weeks after treatment start date

Number and percentages of participants with serum phosphorus levels below, within and above age-dependent normal ranges at baseline, at the end of Stage 1 and at the end of Stage 2. The age related normal ranges for serum phosphorus levels are: * 0 to \<1year 1.36 - 2.62 mmol/L * 1 year to \<6 years 1.03 - 1.97 mmol/L * 6 years to \<9 years 1.03 - 1.97 mmol/L * 9 years to \<10 years 1.03 - 1.97 mmol/L * 10 years to \<15 years 1.00 - 1.94 mmol/L * 15 years to ≤18 years 0.71 - 1.65 mmol/L

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=65 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=15 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage Baseline · Below	1 Participants	1 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage Baseline · Within	24 Participants	5 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage Baseline · Above	40 Participants	9 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage End of Stage 1 · Below	1 Participants	1 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage End of Stage 1 · Within	39 Participants	6 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage End of Stage 1 · Above	24 Participants	8 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage End of Stage 2 · Below	1 Participants	0 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage End of Stage 2 · Within	23 Participants	2 Participants
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage End of Stage 2 · Above	16 Participants	6 Participants

SECONDARY outcome

Timeframe: through study completion, up to 34 weeks after treatment start date

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=65 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=15 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Serum Phosphorus Values at Each Visit Baseline	2.07 mmol/L Standard Deviation 0.522	2.15 mmol/L Standard Deviation 0.669
Serum Phosphorus Values at Each Visit End of Stage 1	1.82 mmol/L Standard Deviation 0.575	2.17 mmol/L Standard Deviation 0.804
Serum Phosphorus Values at Each Visit End of Stage 2	1.71 mmol/L Standard Deviation 0.506	2.09 mmol/L Standard Deviation 0.594

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Serum Total Corrected Calcium at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	-0.06 mmol/L Standard Deviation 0.197	-0.07 mmol/L Standard Deviation 0.207
Serum Total Corrected Calcium at Each Time Point and Change From Baseline Baseline	2.38 mmol/L Standard Deviation 0.144	2.37 mmol/L Standard Deviation 0.185
Serum Total Corrected Calcium at Each Time Point and Change From Baseline End of Stage 1 - Observed data	2.35 mmol/L Standard Deviation 0.212	2.31 mmol/L Standard Deviation 0.130
Serum Total Corrected Calcium at Each Time Point and Change From Baseline End of Stage 2 - Observed data	2.28 mmol/L Standard Deviation 0.185	2.36 mmol/L Standard Deviation 0.154
Serum Total Corrected Calcium at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-0.03 mmol/L Standard Deviation 0.224	-0.06 mmol/L Standard Deviation 0.212

SECONDARY outcome

Timeframe: through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Number and percentages of participants with at least 1 episode of sustained hypercalcaemia (defined as total calcium value above the upper safety limit confirmed by repeat sample 1 week later) during the study

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Participants With Sustained Hypercalcaemia	6 Participants	4 Participants

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Summary statistics of Serum total corrected calcium-phosphorus product at each time point and change from baseline, where serum total corrected calcium-phosphorus product correspond to the product of serum total calcium and Phosphorus, expressed in mmol\^2/L\^2

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline Baseline	4.94 mmol^2/L^2 Standard Deviation 1.400	5.31 mmol^2/L^2 Standard Deviation 1.831
Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline End of Stage 1 - Observed data	4.25 mmol^2/L^2 Standard Deviation 1.392	5.05 mmol^2/L^2 Standard Deviation 1.608
Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline End of Stage 2 - Observed data	3.91 mmol^2/L^2 Standard Deviation 1.211	4.90 mmol^2/L^2 Standard Deviation 1.289
Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-0.65 mmol^2/L^2 Standard Deviation 1.221	-0.31 mmol^2/L^2 Standard Deviation 2.152
Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	-0.49 mmol^2/L^2 Standard Deviation 1.384	-0.12 mmol^2/L^2 Standard Deviation 1.227

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Serum iPTH Levels at Each Time Point and Change From Baseline Baseline	30.36 pmol/L Standard Deviation 26.393	37.12 pmol/L Standard Deviation 19.527
Serum iPTH Levels at Each Time Point and Change From Baseline End of Stage 1 - Observed data	28.28 pmol/L Standard Deviation 20.972	45.90 pmol/L Standard Deviation 28.363
Serum iPTH Levels at Each Time Point and Change From Baseline End of Stage 2 - Observed data	35.60 pmol/L Standard Deviation 32.903	52.30 pmol/L Standard Deviation 36.143
Serum iPTH Levels at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-2.49 pmol/L Standard Deviation 22.139	5.72 pmol/L Standard Deviation 20.166
Serum iPTH Levels at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	4.61 pmol/L Standard Deviation 38.858	12.01 pmol/L Standard Deviation 27.151

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Ferritin Values at Each Time Point and Change From Baseline Baseline	223.67 ug/L Standard Deviation 274.071	234.28 ug/L Standard Deviation 228.825
Ferritin Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	322.59 ug/L Standard Deviation 368.823	310.46 ug/L Standard Deviation 369.869
Ferritin Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	326.13 ug/L Standard Deviation 304.864	345.13 ug/L Standard Deviation 366.230
Ferritin Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	48.59 ug/L Standard Deviation 168.999	59.27 ug/L Standard Deviation 219.660
Ferritin Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	137.57 ug/L Standard Deviation 149.176	110.69 ug/L Standard Deviation 211.054

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline Baseline	28.68 umol/L Standard Deviation 12.985	25.54 umol/L Standard Deviation 14.153
Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	25.37 umol/L Standard Deviation 11.162	27.28 umol/L Standard Deviation 9.671
Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	25.53 umol/L Standard Deviation 11.672	26.04 umol/L Standard Deviation 11.088
Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-3.64 umol/L Standard Deviation 9.284	-0.81 umol/L Standard Deviation 7.176
Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	-4.38 umol/L Standard Deviation 12.454	-3.53 umol/L Standard Deviation 11.779

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Iron Values at Each Time Point and Change From Baseline Baseline	13.20 umol/L Standard Deviation 6.948	15.25 umol/L Standard Deviation 8.488
Iron Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	14.70 umol/L Standard Deviation 7.425	12.66 umol/L Standard Deviation 4.821
Iron Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	14.31 umol/L Standard Deviation 6.005	13.08 umol/L Standard Deviation 4.967
Iron Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	1.64 umol/L Standard Deviation 8.946	-0.18 umol/L Standard Deviation 7.197
Iron Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	1.95 umol/L Standard Deviation 6.940	1.35 umol/L Standard Deviation 9.691

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Transferrin Values at Each Time Point and Change From Baseline Baseline	2.12 g/L Standard Deviation 0.607	1.99 g/L Standard Deviation 0.565
Transferrin Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	1.96 g/L Standard Deviation 0.520	1.97 g/L Standard Deviation 0.588
Transferrin Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	1.89 g/L Standard Deviation 0.513	1.98 g/L Standard Deviation 0.439
Transferrin Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-0.17 g/L Standard Deviation 0.342	-0.05 g/L Standard Deviation 0.234
Transferrin Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	-0.28 g/L Standard Deviation 0.506	-0.12 g/L Standard Deviation 0.289

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline Baseline	83.1 nmol/L Standard Deviation 38.74	81.7 nmol/L Standard Deviation 40.32
25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	79.8 nmol/L Standard Deviation 34.25	74.4 nmol/L Standard Deviation 38.68
25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	76.0 nmol/L Standard Deviation 37.48	59.0 nmol/L Standard Deviation 17.18
25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-4.1 nmol/L Standard Deviation 24.28	-9.7 nmol/L Standard Deviation 22.68
25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	-18.3 nmol/L Standard Deviation 27.77	-21.8 nmol/L Standard Deviation 15.28

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline Baseline	47.77 ug/L Standard Deviation 35.469	55.55 ug/L Standard Deviation 50.249
Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	50.37 ug/L Standard Deviation 42.382	56.15 ug/L Standard Deviation 64.537
Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	55.31 ug/L Standard Deviation 43.363	71.46 ug/L Standard Deviation 64.427
Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	7.29 ug/L Standard Deviation 28.837	2.38 ug/L Standard Deviation 27.375
Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	7.74 ug/L Standard Deviation 41.156	-4.18 ug/L Standard Deviation 38.713

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	4.57 ug/L Standard Deviation 1.549	5.10 ug/L Standard Deviation 1.799
Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	4.21 ug/L Standard Deviation 1.591	4.43 ug/L Standard Deviation 1.565
Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-0.45 ug/L Standard Deviation 1.387	-0.03 ug/L Standard Deviation 1.217
Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline Baseline	4.77 ug/L Standard Deviation 1.201	4.31 ug/L Standard Deviation 1.549
Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	-0.42 ug/L Standard Deviation 1.893	-0.34 ug/L Standard Deviation 0.970

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline Baseline	820.1 pg/mL Standard Deviation 503.90	814.9 pg/mL Standard Deviation 468.89
Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	775.7 pg/mL Standard Deviation 514.86	767.7 pg/mL Standard Deviation 482.47
Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	603.5 pg/mL Standard Deviation 531.86	747.4 pg/mL Standard Deviation 628.27
Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	-60.7 pg/mL Standard Deviation 454.95	-41.8 pg/mL Standard Deviation 729.27
Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	-187.6 pg/mL Standard Deviation 507.26	47.8 pg/mL Standard Deviation 467.87

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Osteocalcin-CL Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	28.4 ug/L Standard Deviation 248.44	20.0 ug/L Standard Deviation 179.26
Osteocalcin-CL Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	20.3 ug/L Standard Deviation 342.77	-91.0 ug/L Standard Deviation 200.09
Osteocalcin-CL Values at Each Time Point and Change From Baseline Baseline	517.9 ug/L Standard Deviation 357.11	681.5 ug/L Standard Deviation 445.94
Osteocalcin-CL Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	586.0 ug/L Standard Deviation 421.72	753.1 ug/L Standard Deviation 412.38
Osteocalcin-CL Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	516.9 ug/L Standard Deviation 429.24	709.0 ug/L Standard Deviation 462.59

SECONDARY outcome

Timeframe: From baseline through study completion, up to 34 weeks after treatment start date

Population: Safety Population: all participants who received at least 1 dose of study medication, analysed according to treatment received.

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=66 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 Participants Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline Baseline	8.86 U/L Standard Deviation 7.646	8.82 U/L Standard Deviation 5.161
Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline End of Stage 1 - Observed data	8.55 U/L Standard Deviation 8.305	8.82 U/L Standard Deviation 5.160
Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline End of Stage 2 - Observed data	8.25 U/L Standard Deviation 5.643	7.62 U/L Standard Deviation 2.044
Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline End of Stage 1 - Change from baseline	0.02 U/L Standard Deviation 2.746	-0.11 U/L Standard Deviation 4.580
Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline End of Stage 2 - Change from baseline	0.72 U/L Standard Deviation 4.108	-0.16 U/L Standard Deviation 2.422

POST_HOC outcome

Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=65 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group >=2 years to <6 years	-0.078 mmol/L Standard Error 0.123	—
Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group >=6 years to <12 years	-0.200 mmol/L Standard Error 0.158	—
Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group >=12 years to <=18 years	-0.149 mmol/L Standard Error 0.062	—

POST_HOC outcome

Timeframe: From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)

The levels of Serum Phosphorus considered at baseline are those above vs within/below Age Related Normal Range

Outcome measures

Outcome measures
Measure	PA21 (Velphoro®) n=65 Participants Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.	Calcium Acetate (Phoslyra®) Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Change in Serum Phosphorus (SP) Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline SP above Age Related Normal Range	-0.282 mmol/L Standard Error 0.096	—
Change in Serum Phosphorus (SP) Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline SP below/within Related Normal Range	0.082 mmol/L Standard Error 0.146	—

Adverse Events

PA21 (Velphoro®)

Serious events: 18 serious events

Other events: 45 other events

Deaths: 0 deaths

Calcium Acetate (Phoslyra®)

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Milica Enoiu / Clinical Research Manager

Vifor Fresenius Medical Care Renal Pharma France

Phone: +41588518264

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No results of the Services or other information on the Clinical Study may be disclosed or submitted for publication or presentation without the Sponsor's prior written agreement.
Publication restrictions are in place

Restriction type: OTHER

Measure	PA21 (Velphoro®) n=66 participants at risk Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 participants at risk Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Investigations Weight increased	3.0% 2/66 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Investigations Blood creatinine increased	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Investigations Blood pressure increased	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Investigations Glomerular filtration rate decreased	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Investigations Weight decreased	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Vascular disorders Hypertension	7.6% 5/66 • Number of events 6 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Vascular disorders Hypotension	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Vascular disorders Vena cava thrombosis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Vascular disorders Venous thrombosis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Vascular disorders Malignant hypertension	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Gastritis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Ileus	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Small intestinal obstruction	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Vomiting	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
General disorders Catheter site haematoma	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
General disorders Oedema peripheral	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
General disorders Puncture site reaction	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
General disorders Pyrexia	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Device related sepsis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Sepsis	1.5% 1/66 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Superinfection	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Tonsillitis streptococcal	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Injury, poisoning and procedural complications Arteriovenous fistula site haematoma	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Product Issues Device malfunction	3.0% 2/66 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Product Issues Device extrusion	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Product Issues Device occlusion	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Cardiac disorders Bradycardia	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Cardiac disorders Cardiac tamponade	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Fluid overload	3.0% 2/66 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Decreased appetite	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Dehydration	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Renal and urinary disorders Azotaemia	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Renal and urinary disorders End stage renal disease	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Renal and urinary disorders Hydronephrosis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Eye disorders Papilloedema	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Nervous system disorders Benign intracranial hypertension	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Respiratory, thoracic and mediastinal disorders Lung disorder	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.

Measure	PA21 (Velphoro®) n=66 participants at risk Formulations: PA21 (Velphoro®), chewable tablets 500 mg and 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg, 250 mg and 125 mg iron Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's age. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.	Calcium Acetate (Phoslyra®) n=19 participants at risk Formulation: Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL. Stage 1 (Open-Label Dose Titration; up to 10 weeks): starting dose based on the participant's weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose was increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time. Stage 2 (Open-Label Safety Extension, 24 week safety extension): dose received at the end of Stage 1, unless a dose change is required. Doses could be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject had been receiving that dose for a minimum of 2 weeks, and for safety/tolerability reasons at any time.
Gastrointestinal disorders Diarrhoea	18.2% 12/66 • Number of events 14 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	0.00% 0/19 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Nausea	12.1% 8/66 • Number of events 10 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	10.5% 2/19 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Vomiting	9.1% 6/66 • Number of events 6 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	10.5% 2/19 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Constipation	6.1% 4/66 • Number of events 4 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Abdominal pain	4.5% 3/66 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Gastrointestinal disorders Abdominal pain upper	3.0% 2/66 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Urinary tract infection	4.5% 3/66 • Number of events 5 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	10.5% 2/19 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Upper respiratory tract infection	3.0% 2/66 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Gastroenteritis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Pharyngitis	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Clostridium difficile colitis	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Clostridium difficile infection	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Conjunctivitis	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Cystitis	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Hand-foot-and-mouth disease	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Hypercalcaemia	6.1% 4/66 • Number of events 4 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	21.1% 4/19 • Number of events 4 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Hyperphosphataemia	4.5% 3/66 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	15.8% 3/19 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Hyperkalaemia	3.0% 2/66 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Iron deficiency	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
General disorders Pyrexia	4.5% 3/66 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
General disorders Catheter site haemorrhage	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Investigations Blood lactate dehydrogenase increased	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Investigations Blood phosphorus increased	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Investigations Liver function test increased	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Renal and urinary disorders Dysuria	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Renal and urinary disorders Haematuria	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Nervous system disorders Headache	3.0% 2/66 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Nervous system disorders Dizziness	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 1/66 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	10.5% 2/19 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Endocrine disorders Hyperparathyroidism	3.0% 2/66 • Number of events 3 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Endocrine disorders Hyperparathyroidism secondary	1.5% 1/66 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Skin and subcutaneous tissue disorders Excessive granulation tissue	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Skin and subcutaneous tissue disorders Rash	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 2 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Ear and labyrinth disorders Otorrhoea	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/66 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.	5.3% 1/19 • Number of events 1 • Through study completion, up to 34 weeks after treatment start date TEAEs (treatment emergent adverse events) are included in this section.