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RECRUITING
NCT06578533
PHASE3

Keeping RAASi Treatment With Optimal Potassium Control

Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

View on ClinicalTrials.gov

Summary

Phase III, multicenter, randomized, open-label, parallel-group, non-inferiority, phase III clinical trial comparing CSZ (Lokelma) vs. iSRAA discontinuation/reduction and/or ARM (standard treatment).

Official title: Phase III, Multicenter, Open-label, Randomized Clinical Trial to Evaluate Efficacy of Sodium Zirconium Cyclosilicate (Lokelma) Compared to Standard of Care to Manage Hyperkalemia in Patients With Chronic Kidney Disease (CKD)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2022-09-30

Completion Date

2026-07-30

Last Updated

2024-08-29

Healthy Volunteers

No

Interventions

DRUG

Sodium Zirconium Cyclosilicate

The recommended starting dose of Lokelma is 10 g, administered three times a day. If, at any time during the study, sK is \> 6.5 mEq/L, treatment for acute hyperkalemia will be started following common clinical practice and local protocols, and investigator will consider RAASi / MRA withdrawal, or downtitration. In this case (confirmed sK \> 6.5 mEq/L despite the maximum SZC dose) patient will leave the IP and will be counted as a treatment failure. If sK is ≤ 3.0 mEq/L, discontinue SZC. The subject should immediately receive appropriate medical intervention. If sK is between 3.1-5.1 mEq/L, pause SZC and re-evaluate in a week. This one-week SCZ treatment temporary discontinuation can only be applied once; if a new sK value between 3.1-5.1 mEq/L is detected, patient will leave the IP permanently. Depending on the serum potassium levels at each visit, the dose of SZC will be adjusted.

Locations (5)

Hospital General Universitario Dr. Balmis

Alicante, Spain

Hospital Universitario Vall d'Hebrón

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitario Doctor Peset

Valencia, Spain