| Trial ID: | L1449 |
| Source ID: | NCT06365684
|
| Associated Drug: |
Sodium Zirconium Cyclosilicate
|
| Title: |
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients with CKD Stage 3b and 4
|
| Acronym: |
LIBRAL
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Hyperkalemia|Diet Modification|Chronic Kidney Disease|Sodium Zirconium Cyclosilicate
|
| Interventions: |
DRUG: Sodium zirconium cyclosilicate
|
| Outcome Measures: |
Primary: The difference of serum potassium at baseline and after six weeks of treatment with potassium enriched diet (non-inferiority design) compared to the control group. With an intention to treat analysis., 6 weeks | Secondary: Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours), 6 weeks|24 hours albuminuria, 6 weeks|urinary potassium (mmol/l), 6 weeks|Plasma bicarbonate, 6 weeks|Quality of life, using SF36 questionnaire, 36-Item Short Form Survey. Scoring can range from 0 to 100. Higher scores indicate better health status, 6 weeks|Effect on stool (assessed with Bristol Stool Chart), Scoring can range form 1 to 7. Where score of 1 indicates obstipation, score of 4 indicates normal defecation and 7 indicates watery defecation., 6 weeks|Difference in serum potassium one week after start of study (SCZ free period), 6 weeks|Per protocol analysis of difference in serum potassium after six week (end of study), 6 weeks|Incidence of severe hyperkalemia (serum potassium above 6.5 mmol/l or above 6.0 with ECG features of hyperkalemia), 6 weeks|Incidence of hyperkalemia (serum potassium above 5.5 mmol/l), 6 weeks|Necessity for treatment of hyperkalemia, 6 weeks|urinary sodium (mmol/l), 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: Leiden University Medical Center | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-04-29
|
| Completion Date: |
2025-05-01
|
| Results First Posted: |
|
| Last Update Posted: |
2025-03-06
|
| Locations: |
Leiden University Medical Center, Leiden, South-Holland, 2333 ZA, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT06365684
|
