Hyperkalemia

Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
NCT05766839 | Phase 2 | Interventional

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

Trial Information
4 Sites
36 Participants
Recruiting
to 11 Years

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SUBMIT
Investigator Site
Jacksonville,Florida,United States,32207
Investigator Site
Kansas City,Missouri,United States,64108
Investigator Site
Jerusalem,Israel,9103102
Investigator Site
Petah tikva,Israel,4920235

Study Eligibility 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.
  • 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who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.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:
  • There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother
  • The breastfeeding mother is

Additional Studies

Additional studies can be found at ClinicalTrials.gov