Clinical Trial: 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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Paediat

Brief 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).

Detailed Summary:
Sponsor: Vifor Fresenius Medical Care Renal Pharma

Current Primary Outcome: Change in serum phosphorus from baseline in the PA21 group [ Time Frame: At the end of Stage 1 (up to 10 weeks after randomization) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in serum phosphorus from baseline in the Phoslyra group [ Time Frame: At end of Stage 1 (up to 10 weeks after randomization) ]
  • Change in serum phosphorus from baseline in the PA21 group [ Time Frame: through study completion, an average of 34 weeks ]
  • Change in serum phosphorus from baseline in the Phoslyra group [ Time Frame: through study completion, an average of 34 weeks ]
  • Percentage of subjects in each stage during which the subject has serum phosphorus levels in the age dependent target ranges. [ Time Frame: through study completion, an average of 34 weeks ]


Original Secondary Outcome: Same as current

Information By: Vifor Fresenius Medical Care Renal Pharma

Dates:
Date Received: February 17, 2016
Date Started: June 2016
Date Completion:
Last Updated: January 16, 2017
Last Verified: January 2017