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

CSL Vifor

Status and phase: Terminated; Phase 3

Conditions: Hyperphosphatemia

Treatments: Drug: PA21 (Velphoro®); Drug: Calcium Acetate (Phoslyra®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02688764

PA-CL-PED-01

Details and patient eligibility

About

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).

Enrollment: 85 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

PA21 (Velphoro®)

Experimental group

Description:

PA21 (Velphoro®), chewable tablets 500 mg iron PA21 (Velphoro®), chewable tablets 250 mg iron PA21 (Velphoro®), powder for oral suspension 500 mg iron PA21 (Velphoro®), powder for oral suspension 250 mg iron PA21 (Velphoro®), powder for oral suspension 125 mg iron

Treatment:

Drug: PA21 (Velphoro®)

Calcium Acetate (Phoslyra®)

Active Comparator group

Description:

Calcium Acetate (Phoslyra®) - Oral Solution: 667 mg calcium acetate per 5 mL.

Treatment:

Drug: Calcium Acetate (Phoslyra®)