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HyperphosphatemiaPhase 3NCT02688764

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

A Phase 3 study testing PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in people with Hyperphosphatemia, run by Vifor Fresenius Medical Care Renal Pharma at 38 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Hyperphosphatemia
What is being tested?
PA21 (Velphoro®) and Calcium Acetate (Phoslyra®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
38 sitesin 7 countries
Study dates
26 May 2016to 21 Feb 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

38 sites in 7 countries.

38 sites in 7 countries

United States22 sites

  • The University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109

  • Emory-Children's Center

    Atlanta, Georgia, 30322-1014

  • University of Alabama at Birmingham School of Medicine

    Birmingham, Alabama, 35233

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601-1914

  • Texas Children's Hospital - Texas Children's Feigin Center

    Houston, Texas, 77030

  • The University of Texas Medical School at Houston

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039-5672

  • University of Miami - Miller School of Medicine

    Miami, Florida, 33136

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Weill Cornell Medical College

    New York, New York, 10021

  • University of Oklahoma Medical Center

    Oklahoma City, Oklahoma, 73104

  • Nemours Children's Clinic - Orlando

    Orlando, Florida, 32827

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Oregon Health and Science University, Doernbecher Children's Hospital

    Portland, Oregon, 97239

  • Primary Children's Hospital

    Salt Lake City, Utah, 84113

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

Poland4 sites

  • Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku

    Bialystok, 15-274

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Uniwersytecki Szpital Dzieciecy w Krakowie - Prokocimiu

    Krakow, 30-663

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw

Other trials in Poland

France3 sites

  • Hôpital Jeanne de Flandre

    Lille

  • Chu de Lyon - Hopital Femme Mere Enfant

    Lyon

  • Service de Néphrologie et Endocrinologie pédiatriques

    Montpellier, 34295

Other trials in France

Russia3 sites

  • Children's Republican Clinical Hospital

    Kazan'

  • St. Vladimir Children's City Clinical Hospital

    Moscow

  • St. Petersburg GBUZ "Children's City Hospital No. 1"

    Saint Petersburg

Other trials in Russia

Germany2 sites

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitätsklinikum Gießen und Marburg GmbH

    Marburg, 35043

Other trials in Germany

Lithuania2 sites

  • Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics

    Kaunas, LT-50009

  • Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos

    Vilnius, 8406

Other trials in Lithuania

Romania2 sites

  • Spitalul Clinic de Urgenţă pentru copii "Maria Sklodowska Curie"

    Bucharest, Bucharest, 077120

  • Spitalul Clinic Fundeni Bucureşti

    Bucharest, Bucharest, 22322

Other trials in Romania

About this study

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

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).

Being tested
PA21 (Velphoro®), Calcium Acetate (Phoslyra®)
Keywords
PA21, phosphate binder
Medical subject headings
Hyperphosphatemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PA21 (Velphoro®)Drug

    Also called sucroferric oxyhydroxide

    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.

  • Calcium Acetate (Phoslyra®)Drug

    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.

Study groups in NCT02688764
Study groupRoleWhat they receive
PA21 (Velphoro®)ExperimentalPA21 (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
Receives: Drug: PA21 (Velphoro®)
Calcium Acetate (Phoslyra®)Active comparatorCalcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.
Receives: Drug: Calcium Acetate (Phoslyra®)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

    Any adverse event Leading to Study Drug Withdrawal is considered.

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

  3. 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.

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

Secondary outcomes (19)

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

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

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

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

  3. 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

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

  4. 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

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

  5. Serum Phosphorus Values at Each Visit

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

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

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

  7. 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

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

  8. 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

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

  9. Serum iPTH Levels at Each Time Point and Change From Baseline

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

  10. Ferritin Values at Each Time Point and Change From Baseline

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

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

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

  12. Iron Values at Each Time Point and Change From Baseline

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

  13. Transferrin Values at Each Time Point and Change From Baseline

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

  14. 25-Hydroxy Vitamin D Values at Each Time Point and Change From Baseline

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

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

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

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

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2016 (estimated)
  2. Study start26 May 2016
  3. Primary completion21 Feb 2019
  4. Study completion21 Feb 2019

Why it 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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02688764
Sponsor's protocol ID
PA-CL-PED-01
Status last verified
Aug 2019
First submitted
17 Feb 2016
Last updated
10 Sep 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40576086

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in people with Hyperphosphatemia, run by Vifor Fresenius Medical Care Renal Pharma at 38 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Poland, France, Russia, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688764, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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