A Study to Investigate the Safety and Efficacy of PA21 (V... | NCT02688764

Label	Type	Description	Intervention Names
PA21 (Velphoro®)	Experimental	PA21 (Velphoro®), chewable tablets 500 mg iron PA21 (Velphoro®), chewable tablets 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg iron PA21 (Velphoro®), powder for oral suspension 250 mg iron PA21 (Velphoro®), powder for oral suspension 125 mg iron	Drug: PA21 (Velphoro®)
Calcium Acetate (Phoslyra®)	Active Comparator	Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.	Drug: Calcium Acetate (Phoslyra®)

Name	Type	Description	Arm Group Labels	Other Names
PA21 (Velphoro®)	Drug	During Stage 1 (Open-Label Dose Titration; up to 10 weeks), PA21 subjects will receive PA21 at a starting dose based on their age. Dose of PA21 will be increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time. During Stage 2 (Open-Label Safety Extension, 24 week safety extension),subjects will continue on the dose received at the end of Stage 1, unless a dose change is required. Doses may be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time during Stage 2.

Measure	Description	Time Frame
Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group		From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)
Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events	Any adverse event Leading to Study Drug Withdrawal is considered.	through study completion, up to 34 weeks after treatment start date
Number and Percentage of Participants With Any Treatment Emergent Adverse Event	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.	through study completion, up to 34 weeks after treatment start date

Measure	Description	Time Frame
Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group		From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)
Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups

Name	Affiliation	Role
Larry A Greenbaum, MD; PhD	Children's Healthcare of Atlanta at Egleston	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham School of Medicine		Birmingham	Alabama	35233	United States
Children's National Medical Center

PubMed Identifier	Type	Citation	Retractions
40576086	Derived	Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 22, 2015	Aug 7, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group

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.

Posted

Least Squares Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG00065

Title

Denominators

Categories

Title	Measurements
	OG000-0.120± 0.081

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	Results are obtained from a linear mixed model which includes change in serum phosphorus levels from baseline to the end of Stage 1 as dependent variable and treatment, baseline serum phosphorus, age (in categories) at randomisation, region (Non-US/US) and gender as fixed effects.	t-test, 2 sided		0.1465	0.05 level of significance													Superiority

Primary

Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events

Any adverse event Leading to Study Drug Withdrawal is considered.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Primary

Number and Percentage of Participants With Any Treatment Emergent Adverse Event

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	Calcium Acetate (Phoslyra®)

Secondary

Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group

Posted

Least Squares Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Secondary

Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups

Posted

Least Squares Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.

Secondary

Serum Phosphorus Values at Each Visit

Posted

Mean

Standard Deviation

mmol/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Serum Total Corrected Calcium at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

mmol/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Participants With Sustained Hypercalcaemia

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline

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

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

Posted

Mean

Standard Deviation

mmol^2/L^2

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

ID	Title	Description
OG000	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.
OG001	Calcium Acetate (Phoslyra®)

Secondary

Serum iPTH Levels at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

pmol/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Ferritin Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

ug/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

umol/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Iron Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

umol/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Transferrin Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

g/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

nmol/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

ug/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

ug/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

pg/mL

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Osteocalcin-CL Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

ug/L

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline

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

Posted

Mean

Standard Deviation

U/L

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

ID	Title	Description
OG000	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.
OG001	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.

Post-Hoc

Change in Serum Phosphorus Level From Baseline to End of Stage 1 in PA21 Group, by Age Group

Posted

Least Squares Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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.

Units	Counts
Participants	OG000

Post-Hoc

Change in Serum Phosphorus (SP) Level From Baseline to End of Stage 1 in PA21 Group, by Serum Phosphorus Level at Baseline

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

Posted

Least Squares Mean

Standard Error

mmol/L

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

ID	Title	Description
OG000	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.

Units	Counts
Participants

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Weight increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected19 at risk
Blood creatinine increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Blood pressure increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Glomerular filtration rate decreased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Weight decreased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Hypertension	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0006 events5 affected66 at risk EG0010 events0 affected19 at risk
Hypotension	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Venous thrombosis	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Malignant hypertension	Vascular disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Catheter site haematoma	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Oedema peripheral	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Puncture site reaction	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Pyrexia	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Device related sepsis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Sepsis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0002 events1 affected66 at risk EG0010 events0 affected19 at risk
Superinfection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Arteriovenous fistula site haematoma	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Device malfunction	Product Issues	MedDRA 19.1	Non-systematic Assessment	EG0003 events2 affected66 at risk EG0010 events0 affected19 at risk
Device extrusion	Product Issues	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Device occlusion	Product Issues	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected19 at risk
Bradycardia	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0010 events0 affected19 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Azotaemia	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Papilloedema	Eye disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Benign intracranial hypertension	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0010 events0 affected19 at risk

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00014 events12 affected66 at risk EG0010 events0 affected19 at risk
Nausea	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG00010 events8 affected66 at risk EG0012 events2 affected19 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0006 events6 affected66 at risk EG0013 events2 affected19 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0004 events4 affected66 at risk EG0011 events1 affected19 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 events3 affected66 at risk EG0011 events1 affected19 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0011 events1 affected19 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0005 events3 affected66 at risk EG0013 events2 affected19 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0012 events1 affected19 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected19 at risk
Pharyngitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected19 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Conjunctivitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Cystitis	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Hand-foot-and-mouth disease	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0004 events4 affected66 at risk EG0014 events4 affected19 at risk
Hyperphosphataemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 events3 affected66 at risk EG0013 events3 affected19 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 events2 affected66 at risk EG0011 events1 affected19 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Pyrexia	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 events3 affected66 at risk EG0011 events1 affected19 at risk
Catheter site haemorrhage	General disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Blood phosphorus increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Liver function test increased	Investigations	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Dysuria	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0011 events1 affected19 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Headache	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 events2 affected66 at risk EG0011 events1 affected19 at risk
Dizziness	Nervous system disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0001 events1 affected66 at risk EG0012 events2 affected19 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected19 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 19.1	Non-systematic Assessment	EG0003 events2 affected66 at risk EG0011 events1 affected19 at risk
Hyperparathyroidism secondary	Endocrine disorders	MedDRA 19.1	Non-systematic Assessment	EG0002 events1 affected66 at risk EG0011 events1 affected19 at risk
Excessive granulation tissue	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0012 events1 affected19 at risk
Otorrhoea	Ear and labyrinth disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 19.1	Non-systematic Assessment	EG0000 events0 affected66 at risk EG0011 events1 affected19 at risk

ID	Term
D010760	Phosphorus Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
C000599459	sucroferric oxyhydroxide
C120662	calcium acetate

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	66	18	66	45	66
EG001	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.	0	19	3	19	14	19