Clinical trial NCT04207203: Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study
Official title: Healthy Diet Rich in Potassium Containing Fruits, Vegetables and Nuts to Chronic Kidney Disease Patients Thought the Use of Sodium Zirconium Cyclosilicate: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease stage4
Chronic Kidney Disease Stage 5
Hyperkalemia
Keywords: Healthy diet
Quality of life
Uremic toxins
Hyperkalemia
Chronic kidney disease
Gut microbiota
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-12-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 6 weeks
measure: Symptoms list
timeFrame: 6 weeks
measure: Energy intake
timeFrame: 6 weeks
measure: Protein intake
timeFrame: 6 weeks
Secondary outcomes:
measure: Plasma potassium
timeFrame: 6 weeks
measure: Short Form Health Survey (SF-36)
timeFrame: 6 weeks
measure: Intestinal obstipation
timeFrame: 6 weeks
measure: Inflammatory marker 1
timeFrame: 6 weeks
measure: Inflammatory marker 2
timeFrame: 6 weeks
measure: Microbiota-derived uremic retention solutes 1
timeFrame: 6 weeks
measure: Microbiota-derived uremic retention solutes 2
timeFrame: 6 weeks
measure: Microbiota-derived uremic retention solutes 3
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References: