A Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate (Phoslyra®) in Paediatric and Adolescent Chronic Kidney Disease (CKD) Patients With Hyperphosphataemia
NCT ID: NCT02688764
Last Updated: 2019-09-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
85 participants
INTERVENTIONAL
2016-05-26
2019-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PA21 (Velphoro®)
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
PA21 (Velphoro®)
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®)
Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.
Calcium Acetate (Phoslyra®)
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.
Interventions
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PA21 (Velphoro®)
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®)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Vifor Fresenius Medical Care Renal Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Larry A Greenbaum, MD; PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Healthcare of Atlanta at Egleston
Locations
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University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Miami - Miller School of Medicine
Miami, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Clinic - Orlando
Orlando, Florida, United States
Emory-Children's Center
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Saint Barnabas Medical Center
Livingston, New Jersey, United States
The University of New Mexico
Albuquerque, New Mexico, United States
Weill Cornell Medical College
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Oklahoma Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Doernbecher Children's Hospital
Portland, Oregon, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital - Texas Children's Feigin Center
Houston, Texas, United States
The University of Texas Medical School at Houston
Houston, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Hôpital Jeanne de Flandre
Lille, , France
Chu de Lyon - Hopital Femme Mere Enfant
Lyon, , France
Service de Néphrologie et Endocrinologie pédiatriques
Montpellier, , France
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, , Germany
Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
Kaunas, , Lithuania
Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos
Vilnius, , Lithuania
Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Uniwersytecki Szpital Dzieciecy w Krakowie - Prokocimiu
Krakow, , Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warsaw, , Poland
Spitalul Clinic de Urgenţă pentru copii "Maria Sklodowska Curie"
Bucharest, Bucharest, Romania
Spitalul Clinic Fundeni Bucureşti
Bucharest, Bucharest, Romania
Children's Republican Clinical Hospital
Kazan', , Russia
St. Vladimir Children's City Clinical Hospital
Moscow, , Russia
St. Petersburg GBUZ "Children's City Hospital No. 1"
Saint Petersburg, , Russia
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PA-CL-PED-01
Identifier Type: -
Identifier Source: org_study_id
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