Potassium Correction for RAAS Optimization in Chronic Kidney Disease

PHASE4RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Chronic Kidney DiseasesHyperkalemiaHypertension
Interventions
DRUG

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.

DRUG

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.

Trial Locations (1)

Unknown

RECRUITING

University Medical Center Groningen, Groningen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amsterdam University Medical Center

OTHER

collaborator

Frisius Medisch Centrum

OTHER

collaborator

Isala

OTHER

collaborator

Vifor Pharma, Inc.

INDUSTRY

collaborator

Dutch Kidney Foundation

OTHER

collaborator

Health Holland

OTHER

lead

University Medical Center Groningen

OTHER