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
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: PA21 (Velphoro®); Calcium Acetate (Phoslyra®)
Intervention description: During Stage 1 (Open-Label Dose Titration; up to 10 weeks), PA21 subjects will receive PA21 at a starting dose based on their age. Dose of PA21 will be increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.
During Stage 2 (Open-Label Safety Extension, 24 week safety extension),subjects will continue on the dose received at the end of Stage 1, unless a dose change is required. Doses may be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time during Stage 2.; During Stage 1 (Open-Label Dose Titration; up to 10 weeks), Phoslyra subjects will receive Phoslyra either at a starting dose based on their weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose of Phoslyra will be increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.
During Stage 2 (Open-Label Safety Extension, 24 week safety extension),subjects will continue on the dose received at the end of Stage 1, unless a dose change is required. Doses may be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time during Stage 2.
Intervention MeSH terms: Calcium; Calcium acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 85.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No
Keywords: PA21; phosphate binder

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).
    

Eligibility criteria:

        Inclusion Criteria:

          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.

        Exclusion Criteria:

          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)