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

NCT04207203 | Completed DMC

• 1 other identifier: ESR-18-13936
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• Patient satisfaction

  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.

  6 weeks

• Symptoms list

  Symptoms list

  6 weeks

• Energy intake

  24-hour food recalls

  6 weeks

• Protein intake

  24-hour food recalls

  6 weeks

Secondary Outcomes (8)

• Plasma potassium

  6 weeks

• Short Form Health Survey (SF-36)

  6 weeks

• Intestinal obstipation

  6 weeks

• Inflammatory marker 1

  6 weeks

• Inflammatory marker 2

  6 weeks

Study Arms (1)

Single arm study

OTHER

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

Interventions

sodium zirconium cyclosilicate and healthy diet COMBINATION_PRODUCT

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.

Single arm study

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• AstraZeneca: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, 14134, Sweden

Location

Related Publications (1)

• Avesani CM, Heimburger O, Rubin C, Sallstrom T, Faxen-Irving G, Lindholm B, Stenvinkel P. Plant-based diet in hyperkalemic chronic kidney disease patients receiving sodium zirconium cyclosilicate: a feasibility clinical trial. Am J Clin Nutr. 2024 Sep;120(3):719-726. doi: 10.1016/j.ajcnut.2024.06.025. Epub 2024 Jul 18.

  PMID: 39032787 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia

Interventions

sodium zirconium cyclosilicate; Diet, Healthy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Nephrologist

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: November 3, 2020
• Primary Completion: April 1, 2023
• Study Completion: May 10, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)