Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578533
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Keeping RAASi Treatment With Optimal Potassium Control
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KEEP-ON
Brief Summary:
Phase III multicenter randomized open-label parallel-group non-inferiority phase III clinical trial comparing CSZ Lokelma vs iSRAA discontinuationreduction andor ARM standard treatment
Detailed Description:
Hyperkalemia is a potentially life-threatening condition associated with ventricular arrhythmias and sudden cardiac arrest It is common in patients with some comorbidities such as chronic kidney disease congestive heart failure cardiovascular disease diabetes or liver disease Most of these patients should receive drugs that block the renin angiotensin aldosterone system RAASi and mineralocorticoid receptor antagonists MRA that increase the risk of hyperkalemia
For these reasons relatively few patients receive maximum doses of RAASi MRA The dose and its usage decline following an hyperkalemia episode However RAASi MRA discontinuation because of hyperkalemia represents an undesirable clinical scenario loosing their potential cardiorenal and nephroprotective benefit Patients on submaximum doses or who discontinued RAASi MRA have worse outcomes than patients on maximum doses
In this study 78 adult patients will be randomized to one of two treatment arms to analyze the proportion of patients achieving sK of 55 mEqL
Control group they will have their treatment with iSRAA andor ARM withdrawn or tapered according to standard clinical practice
Experimental group treatment with iSRAA andor ARM will be maintained and oral treatment with CSZ Lokelma will be added
The study will be conducted in 3 periods
Patient selection Visit 0
Randomization Visit 1
Follow up Visits 2-7
All the patients randomized and completing the treatment assigned will be participating in the study for an stimated period of 90 13 d The clinical trial will be finalized when the last 90-day follow-up of the last patient included is performed
For these reasons relatively few patients receive maximum doses of RAASi MRA The dose and its usage decline following an hyperkalemia episode However RAASi MRA discontinuation because of hyperkalemia represents an undesirable clinical scenario loosing their potential cardiorenal and nephroprotective benefit Patients on submaximum doses or who discontinued RAASi MRA have worse outcomes than patients on maximum doses
In this study 78 adult patients will be randomized to one of two treatment arms to analyze the proportion of patients achieving sK of 55 mEqL
Control group they will have their treatment with iSRAA andor ARM withdrawn or tapered according to standard clinical practice
Experimental group treatment with iSRAA andor ARM will be maintained and oral treatment with CSZ Lokelma will be added
The study will be conducted in 3 periods
Patient selection Visit 0
Randomization Visit 1
Follow up Visits 2-7
All the patients randomized and completing the treatment assigned will be participating in the study for an stimated period of 90 13 d The clinical trial will be finalized when the last 90-day follow-up of the last patient included is performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None