Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age

Launched by VIFOR PHARMA, INC. · Mar 10, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called patiromer to see how well it works and how safe it is for children under 12 years old who have high potassium levels, a condition known as hyperkalemia. High potassium can be serious and needs to be managed carefully. The trial is currently looking for participants, and children who are eligible must be under 12 years old and have been diagnosed with hyperkalemia. They also need to be able to receive regular feeding and medications, and their potassium levels must be above normal on two separate tests.

If a child joins the study, they will be monitored closely for 28 days while receiving the medication. Parents or guardians will need to help with follow-up visits and ensure the child takes the study medication as directed. There are some specific health conditions and medications that may prevent a child from participating, so it's important to discuss eligibility with a healthcare provider. Overall, this trial aims to find out if patiromer can help manage high potassium levels effectively and safely in young children.

Gender

ALL

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