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
Conditions
Interventions
Trade Name: Velphoro 500 mg
Product Name: Velphoro 500 mg
Product Code: PA21
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: s
Sponsors
Vifor Fresenius Medical Care Renal Pharma France
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects 0 to =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of PA21 in reducing serum phosphorus levels in paediatric and adolescent subjects with CKD at the end of Stage 1.; Secondary Objective: • To evaluate the efficacy of PA21 in maintaining the serum phosphorus lowering effects in paediatric and adolescent subjects with CKD at the end of Stage 2. • To evaluate the safety of PA21 in paediatric and adolescent subjects with CKD. • To evaluate the efficacy of Phoslyra in reducing and maintaining serum phosphorus levels in paediatric and adolescent subjects with CKD at the end of Stages 1 and 2. • To evaluate the safety of Phoslyra in paediatric and adolescent subjects with CKD. ; Primary end point(s): Primary Efficacy Endpoint • Change in serum phosphorus from baseline in the PA21 group at the end of Stage 1. Primary Safety Endpoint • Adverse events (AEs) profile. • Percentage of withdrawals due to AEs. ;Timepoint(s) of evaluation of this end point: End of Stage 1 or End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints • Percentage of subjects in each stage during which the subject has serum phosphorus levels in the age dependent target ranges. • Serum phosphorus levels at each time point and change from baseline. Secondary Safety Endpoints • Serum total corrected calcium levels at each time point and change from baseline. • Serum total corrected calcium x phosphorus levels at each time point and Change from baseline. • Serum iPTH levels at each time point and change from baseline. ;Timepoint(s) of evaluation of this end point: End of Stage 1, End of Stafe 2 or End of Study | — |
Countries
France, Germany, Lithuania, Poland, Russian Federation, United States
Contacts
Public ContactMedical Information
Vifor (International) Inc
Outcome results
None listed