Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study
Condition: Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5; Hyperkalemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
Study type: Interventional

Summary: 
      This is a descriptive single arm open-label interventional trial lasting 6 weeks aiming to
      test if a low protein healthy K-rich diet with fruits, vegetables, whole grains, and nuts
      with concomitant use of new potassium binder (SZC) can be safely prescribed to patients with
      chronic kidney disease (CKD) stages 4 and 5 with hyperkalemia. Thirty adult CKD patients with
      hyperkalemia will be included. In the first 3 weeks of the study the plasma K will be
      normalized with the use of SZC and then the participants will receive a fruit basket during 3
      weeks. SZC will be continued thru out the study. Primary end points will be changes in
      patient satisfaction with treatment, patient symptom list, and intake of energy and protein
      before and after the stabilization and healthy diet phase. Secondary outcomes will include
      changes in quality of life, obstipation and circulating gut microbiota-related uremic toxins.
    

Detailed description: 
      Feasibility, descriptive single arm open-label interventional trial lasting 6 weeks. The
      study will recruit 36 CKD patients at the outpatient clinic with: 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. 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) will not be included. Primary end points will be changes in patient
      satisfaction with treatment, patient symptom list, and intake of energy and protein before
      and after the stabilization and healthy diet phase. Secondary outcomes will include changes
      in quality of life, obstipation and circulating gut microbiota-related uremic toxins.
      Intervention: In the first 3 weeks, representing stabilization phase, 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 by a renal
      dietitian. At the end of the first 3 weeks, the patients will be instructed to keep the diet
      with same content of energy and initiate a healthy diet containing 3700 to 4000 mg/potassium
      for 3 weeks (healthy diet phase). In order to increase adherence, a food basket containing
      fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the
      patient and the family 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. Blood measurements, questionnaires related to quality of life and intestinal
      obstipation and measurements of nutritional intake will be performed in the beginning and at
      the end of the stabilization phase and again in the beginning and end of the healthy diet
      phase. Additionally, 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.
    

Intervention name(s): sodium zirconium cyclosilicate and healthy diet
Intervention type(s): Combination Product
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: In the first 3 weeks, stabilization phase, 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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Healthy diet; Quality of life; Uremic toxins; Hyperkalemia; Chronic kidney disease; Gut microbiota