RecruitingPhase 3NCT06578533

Keeping RAASi Treatment With Optimal Potassium Control

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)

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

78 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Diseases

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a potassium-lowering medication can help people with high potassium levels (hyperkalemia) stay on their heart failure medications (called RAASi/MRA — drugs that protect the heart and kidneys), without having to reduce or stop these important drugs because of potassium concerns. **You may be eligible if...** - You have high potassium levels (between 5.0 and 6.5 mEq/L at the start of the study) - You have heart failure and are on RAASi (ACE inhibitor, ARB, or ARNi) and/or MRA therapy - You are receiving standard of care treatment for heart failure **You may NOT be eligible if...** - Your potassium is too low or too high outside the specified ranges - You have severe kidney disease - You have recently had a heart attack or other major cardiac event Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium 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.