Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365684
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-10
Brief Title:
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
LIBRAL
Brief Summary:
Rationale Several studies have shown that higher urinary potassium excretion as proxy for potassium intake is associated with better kidney outcomes lower blood pressure and improved survival These associations are also observed in patients with advanced CKD However application in daily practice in patients with CKD is impaired by the risk of hyperkalemia due to metabolic acidosis and impaired renal potassium excretion in these patients As a consequence patients with CKD are advised to restrict their intake of fruit and vegetables as these healthy food components are important sources of dietary potassium This is particularly undesirable for patients with CKD in view of the very high risk of cardiovascular disease
Concomitant use of sodium zirconium cyclosilicate SZC could allow a more liberal intake of fruit and vegetables for patients with CKD as SZC effectively treats hyperkalemia and counteracts metabolic acidosis 1 With this strategy the beneficial effects of potassium in fruits and vegetables on vascular health could also become accessible to patients with CKD
Objective To demonstrate that a potassium-rich diet including the use of SZC as potential rescue treatment in case of hyperkalemia does not result in an unacceptable rise in plasma potassium ie max rise of 05 mmolL and no hyperkalemia Study Design Investigator initiated single center cross-over randomized clinical trial with non-inferiority design 14 weeks 2 groups regular diets vs diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary Study population Outpatients age 18 years with chronic kidney disease stage IIIbIV and use of inhibitor of the renin-angiotensin system RASi
Intervention Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet Addition of SZC after 1 week in case hyperkaliemia develops serum potassium gt 55 mmolL Weekly measurement of plasma potassium and dose adjustment of SZC if needed
Concomitant use of sodium zirconium cyclosilicate SZC could allow a more liberal intake of fruit and vegetables for patients with CKD as SZC effectively treats hyperkalemia and counteracts metabolic acidosis 1 With this strategy the beneficial effects of potassium in fruits and vegetables on vascular health could also become accessible to patients with CKD
Objective To demonstrate that a potassium-rich diet including the use of SZC as potential rescue treatment in case of hyperkalemia does not result in an unacceptable rise in plasma potassium ie max rise of 05 mmolL and no hyperkalemia Study Design Investigator initiated single center cross-over randomized clinical trial with non-inferiority design 14 weeks 2 groups regular diets vs diet with potassium rich fruits and vegetables with sodium zirconium cyclosilicate if necessary Study population Outpatients age 18 years with chronic kidney disease stage IIIbIV and use of inhibitor of the renin-angiotensin system RASi
Intervention Addition of fruit- and vegetables that contain 40 mmol of potassium on top of regular diet Addition of SZC after 1 week in case hyperkaliemia develops serum potassium gt 55 mmolL Weekly measurement of plasma potassium and dose adjustment of SZC if needed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507823-52 | EUDRACT_NUMBER | None | None |