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New treatment option for Hyperkalemia
Official title Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
ClinicalTrials.gov ID: NCT05766839
What this study is testing
What is Patiromer?
Patiromer is an investigational medicine, given as an once-daily, being studied as a potential treatment for hyperkalemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 11
You may be able to join if
- The following must be met for each participant:
- \- 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...
- \- At screening/baseline, the results from 2 separate and consecutive potassium assessments using the same measurement method (whole blood, plasma...
You likely can't join if
- The following criteria exclude a participant 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who due to their general condition, e.g., anaemia or low body weight, are not suitable to have blood volume withdrawn.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, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease...
- \- A history of or current diagnosis of a severe gastrointestinal (GI) diagnosis or surgery that could affect GI transit of the drug (delayed gastric...
- \- Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer).
See the full eligibility criteria
- The following must be met for each participant:
- \- 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...
- \- 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...
- \- Females of childbearing 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...
- \- 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.
- The following criteria exclude a participant 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, renal artery stenosis, and acute kidney injury (defined by 2012 Kidney Disease Improving Global Outcomes) or a history of acute renal insufficiency in...
- \- 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...
- \- Active cancer, currently on cancer treatment, or history of cancer in the past 2 years (except for non-melanoma skin cancer).
- \- 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 pharmacodynamic/
- 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:
- a)There is suspicion of current alcohol or substance misuse/abuse in breastfeeding mother
- b)The breastfeeding mother is taking potassium supplements
- Other protocol defined Inclusion/Exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Augusta, Georgia, United States
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Kansas City, Missouri, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Amarillo, Texas, United States
- Clayton, Australia
- Parkville, Australia
- Westmead, Australia
- Ghent, Belgium
- Leuven, Belgium
- Helsinki, Finland
- Montpellier, France
- Paris, France
+ 14 more site(s).
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 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Jacksonville, Florida, United States; Miami, Florida, United States; Orlando, Florida, United States; Augusta, Georgia, United States; Peoria, Illinois, United States and 28 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 ClinicalTrials.gov; the study team decides eligibility.