Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
ConditionHyperkalemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age0-11
SponsorVifor Pharma, Inc.
About this trial
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Paediatric participants (<12 years of age) with hyperkalaemia at screening.
Participant's age should not reach 12 years during the 28 days of the pharmacodynamic/dose-ranging period.
Participant is able to receive regular external feeding and medication, including via tubes, i.e., percutaneous endoscopic gastrostomy (PEG) or entero-gastric feeding tube.
At screening/baseline, the results from 2 separate and consecutive potassium assessments using the same measurement method (whole blood, plasma, or serum) need to be above the age-appropriate upper limit of normal (ULN).
Disqualifiers
Preterm birth infants with <37 weeks of gestation cannot be included in Cohort 3.
Participants who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn as specified in the Schedule of Events.
Participants with pseudo-hyperkalaemia due to haemolysis or to abnormally high numbers of platelets (above ULN), leukocytes (above ULN), or erythrocytes (above ULN) at screening based on results obtained from the local laboratory.
Any participant with evidence of potential potassium-related 12-lead electrocardiogram (ECG) changes (i.e., changes consistent with hyper- or hypokalaemia) at screening.
Trial design
Design model
Single group
Treatments tested in this trial
Patiromer
DrugPatiromer will be given once daily; In Cohort 3, depending on the dose and the study participant's age, the total daily dose might be split
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: PatiromerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in potassium levels (mmol/L)
May be measured as serum, plasma, whole blood, potassium
Time frame
From baseline to Day 28Secondary outcomes
1
Change in potassium levels (mmol/L)
May be measured as serum, plasma, whole blood, potassium
Time frame
From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeks2
Occurrence of treatment-emergent adverse events (TEAEs)
Time frame
Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks)3
Occurrence of serious adverse events (SAEs)
Time frame
Part 1: Day 1 up to end of treatment (Day 28 ±3 Days); Part 2: Day 1 up to follow-up visit (Up to 54 weeks)4
Change from baseline in resting heart rate (beats per minute)
Time frame
From baseline to Day 3, Day 7, Day 14, Day 28, and during Part 2: up to 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov