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
Public ClinicalTrials.gov record NCT02688764. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02688764
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 85 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 25, 2016
- Primary completion
- Feb 20, 2019
- Completion
- Feb 20, 2019
- Last update posted
- Sep 9, 2019
2016 – 2019
United States locations
- U.S. sites
- 22
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham School of Medicine | Birmingham | Alabama | 35233 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Miami - Miller School of Medicine | Miami | Florida | 33136 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32827 | — |
| Emory-Children's Center | Atlanta | Georgia | 30322-1014 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601-1914 | — |
| Saint Barnabas Medical Center | Livingston | New Jersey | 07039-5672 | — |
| The University of New Mexico | Albuquerque | New Mexico | 87131-0001 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Oklahoma Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health and Science University, Doernbecher Children's Hospital | Portland | Oregon | 97239 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Texas Children's Hospital - Texas Children's Feigin Center | Houston | Texas | 77030 | — |
| The University of Texas Medical School at Houston | Houston | Texas | 77030 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02688764, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2019 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02688764 live on ClinicalTrials.gov.