Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study (HELPFUL)
Chronic Kidney Disease stage4, Chronic Kidney Disease Stage 5, Hyperkalemia
About this trial
This is an interventional supportive care trial for Chronic Kidney Disease stage4 focused on measuring Healthy diet, Quality of life, Uremic toxins, Hyperkalemia, Chronic kidney disease, Gut microbiota
Eligibility Criteria
Inclusion Criteria:
- age between 18 to 85 years; glomerular filtration rate < 29 ml/min/1.73 m2 and not on dialysis; serum K > 5.1 mmol/L or in previous use of sodium polystyrene sulfonate (SPS) to decrease serum K levels, and who develops hyperkalemia after SPS is ceased.
Exclusion Criteria:
- Patients with serum K > 6.5 mmol/ and those likely to start dialysis within 2 months, with inflammatory bowel syndrome or with a history of hypokalemia (<3.0 mmol/L). Pregnant women.
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Other
Single arm study
During 3 weeks, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.