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Effect of patiromer in children under 12 years of age with high blood potassium levels
EU CTIS ID: 2023-505252-21-00
What this study is testing
To assess change in potassium levels from baseline to Day 28 following administration of different doses of patiromer administered in children 0 to <12 years of age with hyperkalaemia
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Paediatric participants (<12 years of age) with hyperkalaemia at screening.
- If undergoing peritoneal dialysis, participants must be on a stable treatment plan for a minimum of 4 weeks prior to screening, or at least 8 weeks prior to screening if newly initiated on peritoneal dialysis.
- Participant’s age should not reach 12 years during the 28 days of the PD/ dose-ranging period.
- Participant is able to receive regular external feeding and medication, including via tubes, e.g., 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). At least 1 sample needs to be taken at screening/baseline and 1 sample should not be older than 30 days, i.e., a historical sample. The average of the 2 potassium values needs to be above the age appropriate ULN of the measurement method plus 0.5 mEq/l (equivalent to 0.5 mmol/l). If the 2 samples are taken on the day of screening/baseline, the 2 individual potassium values must not differ from each other by more than 0.5 mEq
- In the opinion of the Investigator, the participant is expected to require treatment for hyperkalaemia for at least 28 days upon enrolment in the study.
You likely can't join if
- Preterm birth infants with <37 weeks of gestation cannot be included in Cohort 3.
- Liver enzymes (alanine aminotransferase or aspartate aminotransferase) more than 3 times the ULN at screening, based on the local laboratory, as well as the participant’s respective age
- If the child is being breastfed: a) There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother b) The breastfeeding mother is taking potassium supplements
- 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
- Has severe hypoxaemia, respiratory acidosis, asphyxia, or hypotension 3 months before screening based on assessment of the Investigator.
See the full eligibility criteria
Who can join
- Paediatric participants (<12 years of age) with hyperkalaemia at screening.
- If undergoing peritoneal dialysis, participants must be on a stable treatment plan for a minimum of 4 weeks prior to screening, or at least 8 weeks prior to screening if newly initiated on peritoneal dialysis.
- Participant’s age should not reach 12 years during the 28 days of the PD/ dose-ranging period.
- Participant is able to receive regular external feeding and medication, including via tubes, e.g., 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). At least 1 sample needs to be taken at screening/baseline and 1 sample should not be older than 30 days, i.e., a historical sample. The average of the 2 potassium values needs to be above the age appropriate ULN of the measurement method plus 0.5 mEq/l (equivalent to 0.5 mmol/l). If the 2 samples are taken on the day of screening/baseline, the 2 individual potassium values must not differ from each other by more than 0.5 mEq
- In the opinion of the Investigator, the participant is expected to require treatment for hyperkalaemia for at least 28 days upon enrolment in the study.
- If taking any 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 acceptable representative(s) has provided the appropriate written informed consent, in accordance with local regulations. The assent of the child should also be obtained when appropriate or if requested by the IRB/EC/IEC. The written informed consent must be provided before any study-specific procedures are performed including screening procedures.
- 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 according to the Schedule of Events (Table 1, Table 2) (e.g., able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures); accurately and reliably dispense investigational product as directed.
- Non-Norway sites: Females of child bearingchildbearing 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 prior to 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
What rules you out
- Preterm birth infants with <37 weeks of gestation cannot be included in Cohort 3.
- Liver enzymes (alanine aminotransferase or aspartate aminotransferase) more than 3 times the ULN at screening, based on the local laboratory, as well as the participant’s respective age
- If the child is being breastfed: a) There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother b) The breastfeeding mother is taking potassium supplements
- 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
- Has severe hypoxaemia, respiratory acidosis, asphyxia, or hypotension 3 months before screening based on assessment of the Investigator.
- Participant treated with sodium polystyrene sulphonate, calcium polystyrene sulphonate, or sodium zirconium cyclosilicate within the last 48 hours prior to fulfilling the baseline potassium assessments requested in Inclusion Criterion 4.
- 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
- In the opinion of the Investigator, parent(s) or legal representative(s) inability to comply with the protocol.
- In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, or serious intercurrent illness that would significantly decrease study compliance or jeopardise the safety of the participant or potentially affect the quality of the data such as: hyperkalaemia at screening that requires emergency intervention; cardiovascular event or intervention within 3 months prior to screening; a haemodynamically unstable arrhythmia; hospitalisation for heart failure within the past 3 months; poorly controlled blood pressure; poorly controlled diabetes mellitus or frequent need for adjustment in insulin prescription or recent hospitalisation for treatment of hyper or hypoglycaemia.
- Norway sites only: Females of child-bearing potential (i.e., those who have reached menarche on or before the baseline visit).
- If the child is being breastfed: a) There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother b) The breastfeeding mother is taking potassium supplements
- Participants who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn as specified in the Schedule of Events
- Participant with pseudo-hyperkalaemia due to haemolysis or to abnormally high numbers of platelets (above ULN), leukocytes (above ULN), or erythrocytes (above ULN) at screening based on results obtained from the local laboratory.
- Any participant with evidence of potential potassium-related 12-lead electrocardiogram (ECG) changes (i.e., changes consistent with hyper- or hypokalaemia) at screening.
- Any participant with serum magnesium <1.4 mg/dl (0.58 mmol/l) at screening/baseline.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Peru
- Georgia
- Turkey
- Mexico
- Malaysia
- Israel
- United States
- Lebanon
- Colombia
- Egypt
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peru; Georgia; Turkey; Mexico; Malaysia; Israel and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.