HELPFUL: Healthy Diet Rich in Potassium to Chronic Kidney Disease With Sodium Zirconium Cyclosilicate: A Feasibility Study

Sponsor

Karolinska Institutet (Other)

Overall Status

Recruiting

CT.gov ID

NCT04207203

Collaborator

AstraZeneca (Industry)

Enrollment

Location

Arm

16.8

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Disease stage4 Chronic Kidney Disease Stage 5 Hyperkalemia	Combination Product: sodium zirconium cyclosilicate and healthy diet	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

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.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

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

Actual Study Start Date :

Nov 3, 2020

Anticipated Primary Completion Date :

Mar 30, 2022

Anticipated Study Completion Date :

Mar 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Combination Product: sodium zirconium cyclosilicate and healthy diet 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.

Arm

Intervention/Treatment

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.

Combination Product: sodium zirconium cyclosilicate and healthy diet

Outcome Measures

Primary Outcome Measures

Patient satisfaction [6 weeks]
Renal Treatment Satisfaction Questionnaire (RTSQ). It si based on 13 questions, each varying from 0 to 6. Total score is 78, being the highest score the better.
Symptoms list [6 weeks]
Symptoms list
Energy intake [6 weeks]
24-hour food recalls
Protein intake [6 weeks]
24-hour food recalls

Secondary Outcome Measures

Plasma potassium [6 weeks]
Plasma potassium concentration
Short Form Health Survey (SF-36) [6 weeks]
Short Form Health Survey (SF-36). It is calculated using norm-based scoring, which employs linear transformation to achieve standardized scores with a mean of 50. the highest, the better.
Intestinal obstipation [6 weeks]
Bristol stool chart
Inflammatory marker 1 [6 weeks]
C-reactive protein concentration
Inflammatory marker 2 [6 weeks]
Interleukin 6 concentration
Microbiota-derived uremic retention solutes 1 [6 weeks]
P-cresyl sulfate concentration
Microbiota-derived uremic retention solutes 2 [6 weeks]
Indoxyl-sulfate concentration
Microbiota-derived uremic retention solutes 3 [6 weeks]
Trimethylamine N-oxide concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.