A Phase 3 Study to Investigate the Safety and Efficacy of PA21 (Velphoro®) and Calcium Acetate(Phoslyra®) in Paediatric and Adolescent CKD Patients with Hyperphosphataemia

Phase 1

• Conditions: Control of serum phosphorus levels in paediatric and adolescent subjects with chronic kidney disease (CKD).; MedDRA version: 20.0 Level: LLT Classification code 10076411 Term: Chronic kidney disease stage 4 System Organ Class: 100000004857; MedDRA version: 20.0 Level: LLT Classification code 10076412 Term: Chronic kidney disease stage 5 System Organ Class: 100000004857; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2015-004155-43-DE
• Lead Sponsor: Vifor Fresenius Medical Care Renal Pharma France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Study Completion: 2019-02-21
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 85

Inclusion Criteria

1. Subjects 0 to <18 years at time of consent.
2. Subjects with hyperphosphataemia
3. Subjects who are Phosphate Binder (PB) naïve or have been receiving stable doses of a PB(s) for at least 1 month prior to screening. Subjects may be on stable doses of a maximum of 2 PBs. Subjects who have been receiving PBs will enter an obligatory washout period depending on serum phosphorus levels
4. 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.
5. Subjects <1 year must have CKD.
6. PD subjects must have had 1 month of unchanged PD prescription (volume and number of exchanges). Home HD subjects may be included (no nocturnal HD (overnight stay at site) will be allowed).
7. Appropriate written informed consent and, where appropriate/required assent, have been provided.
Are the trial subjects under 18? yes
Number of subjects for this age range: 130
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Subjects with hypercalcaemia at screening
2. Subjects with intact parathyroid hormone (iPTH) levels >700 pg/mL at screening.
3. Subjects with hypocalcaemia (serum total corrected calcium <1.9 mmol/L; <7.6 mg/dL) at screening.
4. Subjects with raised alanine aminotransferase or aspartate aminotransferase >3 times the upper limit of the normal range based on central laboratory results at screening.
5. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.
6. If of child-bearing potential, subject is not using adequate contraceptive precautions. Subject must agree to use a highly effective method of birth control during the study and for 1 month after the last dose of study medication. Adequate methods of birth control are defined as those which result in a low failure rate (i.e., <1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner. Non-child-bearing potential includes being surgically sterilised at least 6 months prior to the study.
7. Subject has a significant medical condition(s) or anticipated need for major surgery during the study or history of major gastrointestinal surgery or any other kind of disorder that may be associated with increased risk to the subject, or may interfere with study assessments or outcomes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified