50
Participants
Start Date
April 1, 2024
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
Patiromer 8400 MG [Veltassa]
Patiromer is a cation-exchanging polymer intended for oral intake that is not resorbed from the gastro-intestinal tract. Patiromer has been approved by the European Medicines Agency (EMA) and is available for clinical use in The Netherlands for the indication of hyperkalemia in adults. It contains calcium-sorbitol complex as a counter-ion. Patiromer increases the faecal excretion of potassium in the gastro-intestinal lumen by exchange with part of the calcium. This results in a lower concentration of free potassium in the gastro-intestinal lumen, reducing in turn plasma potassium concentration. After initiation of patiromer, a clinically significant reduction in plasma potassium can be observed at around 7 hours, the effect persists for approximately 24 hours. Patiromer is excreted by the fecal route, 24-48 hrs after ingestion. Since patiromer is not absorbed or metabolized by the body, other drugs are not expected to influence the efficacy of patiromer.
Placebo
Placebo is a powder with a similar appearance, smell, and taste as patiromer, but without and clinically detectable effects. It is intended for oral intake.
RECRUITING
University Medical Center Groningen, Groningen
Collaborators (1)
Amsterdam University Medical Center
OTHER
Frisius Medisch Centrum
OTHER
Isala
OTHER
Vifor Pharma, Inc.
INDUSTRY
Dutch Kidney Foundation
OTHER
Health Holland
OTHER
University Medical Center Groningen
OTHER