An 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
This 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).
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
Hyperphosphatemia PA21 phosphate binder Calcium, Dietary Calcium acetate Ferric Compounds
You can join if…
Open to people ages up to 18 years
- 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 CAN'T join 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)
- University of California, San Francisco, Medical Center at Parnassus accepting new patients
San Francisco, California, 94158, United States
- Primary Children's Hospital accepting new patients
Salt Lake City, Utah, 84113, United States
- The University of New Mexico accepting new patients
Albuquerque, New Mexico, 87131-0001, United States
- University of Oklahoma Medical Center accepting new patients
Oklahoma City, Oklahoma, 73104, United States
- The University of Texas Southwestern Medical Center accepting new patients
Dallas, Texas, 75390, United States
- Texas Children's Hospital - Texas Children's Feigin Center accepting new patients
Houston, Texas, 77030, United States
- University of Iowa Hospitals and Clinics accepting new patients
Iowa City, Iowa, 52242, United States
- Washington University School of Medicine in St. Louis accepting new patients
St. Louis, Missouri, 63110, United States
- Children's Hospital of Wisconsin accepting new patients
Milwaukee, Wisconsin, 53226, United States
- University of Alabama at Birmingham School of Medicine accepting new patients
Birmingham, Alabama, 35233, United States
- University of Michigan Hospital accepting new patients
Ann Arbor, Michigan, 48109, United States
- Emory-Children's Center accepting new patients
Atlanta, Georgia, 30322-1014, United States
- Women & Children's Hospital of Buffalo accepting new patients
Buffalo, New York, 14222, United States
- Duke University Medical Center accepting new patients
Durham, North Carolina, 27710, United States
- Nemours Children's Clinic - Orlando accepting new patients
Orlando, Florida, 32827, United States
- Children's National Medical Center accepting new patients
Washington, District of Columbia, 20010, United States
- Nicklaus Children's Hospital accepting new patients
Miami, Florida, 33155, United States
- Saint Barnabas Medical Center accepting new patients
Livingston, New Jersey, 07039-5672, United States
- Hackensack University Medical Center accepting new patients
Hackensack, New Jersey, 07601-1914, United States
- Weill Cornell Medical College accepting new patients
New York, New York, 10021, United States
- Chu de Lyon - Hopital Femme Mere Enfant accepting new patients
- Service de Néphrologie et Endocrinologie pédiatriques accepting new patients
Montpellier cedex 5, 34295, France
- CHU Purpan accepting new patients
Toulouse Cedex 9, 31059, France
- Universitätsklinikum Erlangen accepting new patients
Erlangen, 91054, Germany
- Universitätsklinikum Gießen und Marburg GmbH accepting new patients
Marburg, 35043, Germany
- Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics accepting new patients
Kaunas, LT-50009, Lithuania
- Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos accepting new patients
Vilnius, 8406, Lithuania
- Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku accepting new patients
Białystok, 15-274, Poland
- Uniwersyteckie Centrum Kliniczne accepting new patients
Gdansk, 80-952, Poland
- Uniwersytecki Szpital Dzieciecy w Krakowie - Prokocimiu accepting new patients
Krakow, 30-663, Poland
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02688764.