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

Mass General Brigham

Status and phase: Unknown; Phase 1

Conditions: Hyperkalemia; Chronic Kidney Diseases

Treatments: Drug: Sodium Zirconium Cyclosilicate Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT04727840

2020P000975

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over the age of 18
• CKD stage 3-4 with an estimated GFR less or equal to 45 mL/min but greater than 15 mL/min
• Serum potassium level ≥5 mEq/L on two blood tests in the past 3 months but less than 6.5mEq/L

Exclusion criteria

• On dialysis
• Have been on SZC in the past 3 months
• Reside in a nursing home
• Pregnant patients
• Patients with known cognitive disability
• History of bowel disease such as but not limited to short bowel syndrome, bowel obstruction, inflammatory bowel disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention

Other group

Description:

All 20 CKD patients will be receiving a potassium binder while consuming a tailored diet of non-potassium restricted foods

Treatment:

Drug: Sodium Zirconium Cyclosilicate Oral Product