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
Qualifiers
- 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who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.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
Treatments tested in this trial
- Patiromer
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov