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

Stopped early · Phase 3

Conditions studied: Hyperphosphatemia

In brief

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).

Key facts

Study ID

NCT02688764

Run by

Vifor Fresenius Medical Care Renal Pharma

People needed

85

Starts

2016-05-26

Expected to finish

2019-02-21

Last updated by the study team

2019-09-10

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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