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

Summary

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).

Timeline

Start

2016-05-26

Primary completion

2019-02-21

Completion

2019-02-21

Outcome

Missed primary endpoint

Stopped: “The study was prematurely ended due to the modification of study requirements by the US Food and Drug Administration and the European Medicines Agency”

registry analysis (superiority test); PA21 (Velphoro®); p = 0.1465; t-test, 2 sided; note: 0.05 level of significance NCT02688764 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PA21	Unknown	—	Oral
Comparator	calcium acetate	Other / unclassified	—	Oral

Indications