NCT05766839 · Vifor Pharma, Inc.
Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
What this study is about
A study to evaluate the how the drug affects the body effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia
View original scientific description
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia
Interventions
DRUG
Patiromer
Patiromer will be given once daily; In Cohort 3, depending on the dose and the study participant's age, the total daily dose might be split
Primary outcome measures
Change in potassium levels (mmol/L)
Time frame: From baseline to Day 28
May be measured as serum, plasma, whole blood, potassium
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Aurora, Colorado
- Jacksonville, Florida
- Miami, Florida
- Orlando, Florida
- Augusta, Georgia
- Peoria, Illinois
- Boston, Massachusetts
- Kansas City, Missouri
- Durham, North Carolina
- Philadelphia, Pennsylvania
- Nashville, Tennessee
- Amarillo, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations