Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-31 @ 12:38 PM
Study NCT ID:
NCT06578533
Status:
RECRUITING
Last Update Posted:
2024-08-29
First Post:
2024-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Keeping RAASi Treatment With Optimal Potassium Control
Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Organization:
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:
False
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 discontinuation/reduction and/or 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 \< 5.5 mEq/L:
* Control group: they will have their treatment with iSRAA and/or ARM withdrawn or tapered, according to standard clinical practice.
* Experimental group: treatment with iSRAA and/or 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 \< 5.5 mEq/L:
* Control group: they will have their treatment with iSRAA and/or ARM withdrawn or tapered, according to standard clinical practice.
* Experimental group: treatment with iSRAA and/or 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:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: