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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

Primary Purpose

Hyperphosphatemia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PA21 (Velphoro®)
Calcium Acetate (Phoslyra®)
Sponsored by
Vifor Fresenius Medical Care Renal Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring PA21, phosphate binder

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects 0 to <18 years at time of consent.
  2. Subjects with hyperphosphataemia
  3. Subjects ≥1 year with CKD Stages 4-5 defined by a glomerular filtration rate <30 mL/min/1.73 m2 or with CKD Stage 5D receiving adequate maintenance haemodialysis (HD) or peritoneal dialysis (PD) for at least 2 months prior to screening.
  4. Subjects <1 year must have CKD.
  5. Appropriate written informed consent and, where appropriate/required assent, have been provided.

Exclusion Criteria:

  1. Subjects with hypercalcaemia at screening
  2. Subjects with intact parathyroid hormone (iPTH) levels >700 pg/mL at screening.
  3. Subjects who are PB naïve who weigh <5 kg at screening. Subjects receiving stable doses of PBs who weigh <6 kg at screening
  4. Subjects requiring feeding tube sizes ≤6 FR (French catheter scale).
  5. Subjects with history of major gastrointestinal surgery or significant gastrointestinal disorders.
  6. Subjects with hypocalcaemia (serum total corrected calcium <1.9 mmol/L; <7.6 mg/dL) at screening.
  7. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
  8. Subject has a significant medical condition(s)

Sites / Locations

  • University of Alabama at Birmingham School of Medicine
  • Children's National Medical Center
  • University of Miami - Miller School of Medicine
  • Nicklaus Children's Hospital
  • Nemours Children's Clinic - Orlando
  • Emory-Children's Center
  • University of Iowa Hospitals and Clinics
  • University of Michigan Hospital
  • Washington University School of Medicine in St. Louis
  • Hackensack University Medical Center
  • Saint Barnabas Medical Center
  • The University of New Mexico
  • Weill Cornell Medical College
  • Duke University Medical Center
  • University of Oklahoma Medical Center
  • Oregon Health and Science University, Doernbecher Children's Hospital
  • The Children's Hospital of Philadelphia
  • The University of Texas Southwestern Medical Center
  • Texas Children's Hospital - Texas Children's Feigin Center
  • The University of Texas Medical School at Houston
  • Primary Children's Hospital
  • Children's Hospital of Wisconsin
  • Hôpital Jeanne de Flandre
  • Chu de Lyon - Hopital Femme Mere Enfant
  • Service de Néphrologie et Endocrinologie pédiatriques
  • Universitätsklinikum Erlangen
  • Universitätsklinikum Gießen und Marburg GmbH
  • Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
  • Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos
  • Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku
  • Uniwersyteckie Centrum Kliniczne
  • Uniwersytecki Szpital Dzieciecy w Krakowie - Prokocimiu
  • Instytut "Pomnik - Centrum Zdrowia Dziecka"
  • Spitalul Clinic de Urgenţă pentru copii "Maria Sklodowska Curie"
  • Spitalul Clinic Fundeni Bucureşti
  • Children's Republican Clinical Hospital
  • St. Vladimir Children's City Clinical Hospital
  • St. Petersburg GBUZ "Children's City Hospital No. 1"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PA21 (Velphoro®)

Calcium Acetate (Phoslyra®)

Arm Description

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

Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.

Outcomes

Primary Outcome Measures

Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group
Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events
Any adverse event Leading to Study Drug Withdrawal is considered.
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.

Secondary Outcome Measures

Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group
Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups
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
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
Serum Phosphorus Values at Each Visit
Serum Total Corrected Calcium at Each Time Point and Change From Baseline
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
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
Serum iPTH Levels at Each Time Point and Change From Baseline
Ferritin Values at Each Time Point and Change From Baseline
Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline
Iron Values at Each Time Point and Change From Baseline
Transferrin Values at Each Time Point and Change From Baseline
25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline
Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline
Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline
Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline
Osteocalcin-CL Values at Each Time Point and Change From Baseline
Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline

Full Information

First Posted
February 17, 2016
Last Updated
August 28, 2019
Sponsor
Vifor Fresenius Medical Care Renal Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02688764
Brief Title
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
Official Title
An Open-label, Randomised, Active-controlled, Parallel Group, Multicentre, Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients With Hyperphosphataemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely ended due to the modification of study requirements by the US Food and Drug Administration and the European Medicines Agency
Study Start Date
May 26, 2016 (Actual)
Primary Completion Date
February 21, 2019 (Actual)
Study Completion Date
February 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vifor Fresenius Medical Care Renal Pharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a Phase 3, Open-label, Randomised, Active-controlled, Parallel Group, Multicentre Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia. The aim of this Phase 3 clinical study is to demonstrate similar efficacy of PA21 (Velphoro) in paediatric and adolescent patients with CKD, and to provide safety and dosing information for this patient population. The Phoslyra (comparator) group provides information for a descriptive comparison of PA21 against a commonly used calcium-based phosphate binder (calcium acetate).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
PA21, phosphate binder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PA21 (Velphoro®)
Arm Type
Experimental
Arm Description
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
Arm Title
Calcium Acetate (Phoslyra®)
Arm Type
Active Comparator
Arm Description
Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.
Intervention Type
Drug
Intervention Name(s)
PA21 (Velphoro®)
Other Intervention Name(s)
sucroferric oxyhydroxide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium Acetate (Phoslyra®)
Intervention Description
During Stage 1 (Open-Label Dose Titration; up to 10 weeks), Phoslyra subjects will receive Phoslyra either at a starting dose based on their weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose of Phoslyra 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.
Primary Outcome Measure Information:
Title
Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the PA21 Group
Time Frame
From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)
Title
Number and Percentage of Participants Who Withdrew Due to Treatment Emergent Adverse Events
Description
Any adverse event Leading to Study Drug Withdrawal is considered.
Time Frame
through study completion, up to 34 weeks after treatment start date
Title
Number and Percentage of Participants With Any Treatment Emergent Adverse Event
Description
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.
Time Frame
through study completion, up to 34 weeks after treatment start date
Secondary Outcome Measure Information:
Title
Change in Serum Phosphorus Level From Baseline to the End of Stage 1 in the Phoslyra Group
Time Frame
From Baseline to the End of Stage 1 (up to 10 weeks after treatment start date)
Title
Change in Serum Phosphorus Level From Baseline to the End of Stage 2 in Both Groups
Time Frame
From baseline to study completion, up to 34 weeks after treatment start date
Title
Participants With Serum Phosphorus Levels Within the Age-dependent Target Range in Each Stage
Description
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
Time Frame
through study completion, up to 34 weeks after treatment start date
Title
Participants With Serum Phosphorus Levels Within the Age Related Normal Range in Each Stage
Description
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
Time Frame
through study completion, up to 34 weeks after treatment start date
Title
Serum Phosphorus Values at Each Visit
Time Frame
through study completion, up to 34 weeks after treatment start date
Title
Serum Total Corrected Calcium at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Participants With Sustained Hypercalcaemia
Description
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
Time Frame
through study completion, up to 34 weeks after treatment start date
Title
Serum Total Corrected Calcium-Phosphorus Product at Each Time Point and Change From Baseline
Description
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
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Serum iPTH Levels at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Ferritin Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Unsaturated Iron Binding Capacity Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Iron Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Transferrin Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Bone Specific Alkaline Phosphatase Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Type I Collagen C-Telopeptides Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Fibroblast Growth Factor 23 Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Osteocalcin-CL Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date
Title
Tartrate-resistant Acid Phosphatase 5b Values at Each Time Point and Change From Baseline
Time Frame
From baseline through study completion, up to 34 weeks after treatment start date

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects 0 to <18 years at time of consent. Subjects with hyperphosphataemia Subjects ≥1 year with CKD Stages 4-5 defined by a glomerular filtration rate <30 mL/min/1.73 m2 or with CKD Stage 5D receiving adequate maintenance haemodialysis (HD) or peritoneal dialysis (PD) for at least 2 months prior to screening. Subjects <1 year must have CKD. Appropriate written informed consent and, where appropriate/required assent, have been provided. Exclusion Criteria: Subjects with hypercalcaemia at screening Subjects with intact parathyroid hormone (iPTH) levels >700 pg/mL at screening. Subjects who are PB naïve who weigh <5 kg at screening. Subjects receiving stable doses of PBs who weigh <6 kg at screening Subjects requiring feeding tube sizes ≤6 FR (French catheter scale). Subjects with history of major gastrointestinal surgery or significant gastrointestinal disorders. Subjects with hypocalcaemia (serum total corrected calcium <1.9 mmol/L; <7.6 mg/dL) at screening. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding. Subject has a significant medical condition(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry A Greenbaum, MD; PhD
Organizational Affiliation
Children's Healthcare of Atlanta at Egleston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham School of Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Miami - Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Nemours Children's Clinic - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Emory-Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1014
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601-1914
Country
United States
Facility Name
Saint Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039-5672
Country
United States
Facility Name
The University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Oklahoma Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health and Science University, Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Texas Children's Hospital - Texas Children's Feigin Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hôpital Jeanne de Flandre
City
Lille
Country
France
Facility Name
Chu de Lyon - Hopital Femme Mere Enfant
City
Lyon
Country
France
Facility Name
Service de Néphrologie et Endocrinologie pédiatriques
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos
City
Vilnius
ZIP/Postal Code
8406
Country
Lithuania
Facility Name
Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku
City
Białystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Uniwersytecki Szpital Dzieciecy w Krakowie - Prokocimiu
City
Krakow
ZIP/Postal Code
30-663
Country
Poland
Facility Name
Instytut "Pomnik - Centrum Zdrowia Dziecka"
City
Warszawa
Country
Poland
Facility Name
Spitalul Clinic de Urgenţă pentru copii "Maria Sklodowska Curie"
City
Bucureşti
State/Province
Bucharest
ZIP/Postal Code
077120
Country
Romania
Facility Name
Spitalul Clinic Fundeni Bucureşti
City
București
State/Province
Bucharest
ZIP/Postal Code
22322
Country
Romania
Facility Name
Children's Republican Clinical Hospital
City
Kazan
Country
Russian Federation
Facility Name
St. Vladimir Children's City Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
St. Petersburg GBUZ "Children's City Hospital No. 1"
City
Saint Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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