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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507823-52 | EudraCT Number |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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 (i.e. max rise of 0.5 mmol/L 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 IIIb/IV 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 > 5,5 mmol/L). Weekly measurement of plasma potassium and dose adjustment of SZC if needed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Potassium enriched diet | Experimental | Patients with chronic kidney disease stage 3b to 4 will be treated for 6 weeks with a potassium enriched diet (adding +40mmol/day in the form of fruits/vegetables/nuts) |
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| Regular diet | No Intervention | Patients with chronic kidney disease stage 3b to 4 will followed for 6 weeks, during their regular diet |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium zirconium cyclosilicate | Drug | In the case of hyperkalemia patients will be treated with Sodium zirconium cyclosilicate to allow the continuation of potassium enriched diet. In case hyperkalemia arises in the control group, patients will be treated with Sodium zirconium cyclosilicate as well. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulatory blood pressure (average systolic and diastolic blood pressure over 24 hours) | 6 weeks | |
| 24 hours albuminuria | 6 weeks | |
| urinary potassium (mmol/l) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joris I Rotmans, Professor | Contact | +31 71 5292148 | j.i.rotmans@lumc.nl | |
| Wouter T Moest, MD | Contact | +31 71 5292148 | w.t.moest@lumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | South Holland | 2333 ZA | Netherlands |
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Single center, cross-over randomized clinical trial with non-inferiority design
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| 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 |
| ID | Term |
|---|---|
| D006947 | Hyperkalemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000597310 | sodium zirconium cyclosilicate |
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