NCT04727840

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Chronic Kidney Diseases
• Hyperkalemia

Interventions

Type	Name	Description
DRUG	Sodium Zirconium Cyclosilicate Oral Product	Sodium zirconium cyclosilicate (SZC), a non-absorbed cation exchanger, selectively binds potassium in the intestine. SZC is in a powder form and will be provided to patients in packets containing 5g or 10gm of the medication. Participants will mix the contents of one packet with water (about 45mL). The drink should be stirred and drank immediately. If powder remains in the glass, then water should be added and the remainder of the drink should be consumed. Other medications should be taken 2 hours before or after SZC. At Day 0 and Day 1, participants will be taking SZC at 10gm three times a day. A serum potassium will be checked on Day 2; if serum potassium is \<5.1mEq/L, then the dose will be decreased to the maintenance dose of 5gm per day. At each serum potassium checks, the medication dosage will be adjusted accordingly.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-01-15
• Completion: 2022-01-15
• First posted: 2021-01-27
• Last updated: 2021-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study