Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
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who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.
Any of the following renal conditions: maintenance haemodialysis, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes) or a history of acute renal insufficiency in the past 3 months. Note: Chronic kidney disease (CKD) is not excluded.
A history of or current diagnosis of a severe gastrointestinal (GI) diagnosis or surgery that could affect GI transit of the drug (delayed gastric emptying), such as a severe swallowing disorder, severe gastroesophageal reflux, uncorrected pyloric stenosis, intussusception, any other intestinal obstruction (e.g., Hirschsprung disease, chronic intestinal pseudo-obstruction, clinically significant postsurgical abdominal adhesions) or any gut-shortening surgical procedure prior to screening. Pre-gastric above-mentioned pathologies may be disregarded in case of existence of a PEG or entero-gastric feeding tube, as the PEG or entero-gastric feeding tube will serve for nutrition and investigational product administration.
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
32 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
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Source ClinicalTrials.gov