NCT05766839 Patiromer for Treatment of Hyperkalaemia in Children Under 12 Years of Age
| NCT ID | NCT05766839 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Vifor Pharma, Inc. |
| Condition | Hyperkalemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-04-06 |
| Primary Completion | 2029-12-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
A study to evaluate the pharmacodynamic effects, safety, and tolerability of patiromer in children under 12 years of age with hyperkalaemia.
Eligibility Criteria
Inclusion Criteria: * The following inclusion criteria 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 (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 auth