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Summary

Eligibility
for people ages up to 18 years
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

Summary

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).

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

Keywords

Hyperphosphatemia PA21 phosphate binder Calcium, Dietary Calcium acetate Ferric Compounds

Eligibility

You can join if…

Open to people ages up to 18 years

  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.

You CAN'T join if...

  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)

Locations

  • 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
    Lyon, France
  • 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

Details

Status
accepting new patients
Start Date
Sponsor
Vifor Fresenius Medical Care Renal Pharma
ID
NCT02688764
Phase
Phase 3
Lead Scientist
Paul Brakeman
Study Type
Interventional
Last Updated
January 1, 2017
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