Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)

Chronic Kidney Diseases Clinical Trial

Official title: Combined Dietary Intervention in Hyperkalemic CKD Patients With Potassium Binder (With Hyperkalemia) (DiPo Trial)

Status Not yet recruiting

Clinical Trial Summary

This study hypothesizes that the administration of Sodium zirconium cyclosilicate in CKD patients with hyperkalemia while avoiding dietary potassium restriction will normalize their serum potassium levels. Additionally, we aim to assess the effects of a high potassium diet on renal function, endothelial function, acidosis, systemic inflammatory status and gut microbiota.

Clinical Trial Description

A diet rich in fruits and vegetables is associated with better outcomes in CKD patients. However, the presence of hyperkalemia can prevent patients from increasing plant-based foods in their diets. While hyperkalemia can have severe health consequences in advanced CKD, the decreased consumption of plant-based foods can be associated with adverse health outcomes in this population.

Sodium zirconium cyclosilicate (SZC) is a non-absorbed cation exchanger that selectively binds potassium in the intestine.

This study plans to enroll CKD patients with an eGFR ≤45mL/min and a serum potassium ≥ 5mEq/L, administering SZC to achieve normokalemia, and provide them with a diet rich in fruits and vegetables. Endothelial function, inflammatory biomarkers and stool microbiota will be measured to assess the potential benefits of providing a diet rich in fruits and vegetables, albeit rich in potassium, in advanced CKD patients. Because these patients are usually restricting the intake of plant-based proteins and foods due to the concerns of hyperkalemia, eliminating this serious and potentially-life threatening clinical condition might carry health benefits, such as improved endothelial function and decreased inflammation ;

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hyperkalemia
• Kidney Diseases
• Renal Insufficiency, Chronic

• NCT number: NCT04727840
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Contact: Lea Borgi, MD, MMSc
• Phone: 617-264-3053
• Email: lborgi@bwh.harvard.edu
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 15, 2021
• Completion date: January 15, 2022