patiromer for treatment of hyperkalaemia in children under 12 years of age

Conditions: Hyperkalemia

Summary: a study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia


Eligibility criteria:
inclusion criteria: the following inclusion criteria must be met for each subject: * paediatric subjects (\<12 years of age) with hyperkalaemia at screening. * subject's age should not reach 12 years during the 28 days of the pharmacodynamic (pd)/dose-ranging period. * subject is able to receive regular external feeding and medication, including via tubes, e.g., 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 uln. * if taking any renin-angiotensin aldosterone system inhibitors (raasi), beta blockers, fludrocortisone, or diuretic medications, must be on a stable dose for at least 14 days prior to screening. * parent(s) or legally authorised representative(s) or another appropriate person delegated by the legally authorised representatives must be available to help the study-site personnel ensure follow-up; accompany the participant to the study site on each assessment day; accurately and reliably dispense investigational product as directed. * females of child bearing potential must be non-lactating, must have a negative pregnancy test at screening, and must have used an effective, acceptable form of contraception (e.g., abstinence) for at least 1 month before patiromer administration. females of child bearing potential must agree to continue using contraception throughout the study and for 1 month after the last dose of patiromer. exclusion criteria: the following criteria exclude a subject from participating in this trial: * 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who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.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 or peritoneal dialysis, 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. * active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer). * recipient of any organ transplant requiring treatment with immunosuppressive therapy or scheduled for kidney transplant procedure during the first 28 days after day 1. * history of sudden infant death in a sibling (only for participants \<2 years of age at screening). * use of the following medications if doses have not been stable for at least 14 days prior to screening or if doses are anticipated to change during the 4-week pd/ dose-ranging period: digoxin, bronchodilators, theophylline, heparins (including low molecular heparins), tacrolimus, mycophenolate mofetil, cyclosporine, trimethoprim, or cotrimoxazole. * use of any investigational product for an unapproved indication within 30 days prior to screening or within 5 half-lives, whichever is longer. * known hypersensitivity to patiromer or its components. * if the child is being breastfed: 1. there is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother 2. the breastfeeding mother is taking potassium supplements other protocol defined inclusion/exclusion criteria may apply