Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)
- Conditions
- Chronic Kidney DiseasesHyperkalemia
- Interventions
- Drug: Sodium Zirconium Cyclosilicate Oral Product
- Registration Number
- NCT04727840
- Lead Sponsor
- Brigham and Women's Hospital
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Sodium Zirconium Cyclosilicate Oral Product All 20 CKD patients will be receiving a potassium binder while consuming a tailored diet of non-potassium restricted foods
- Primary Outcome Measures
Name Time Method Normalization of Serum Potassium level 2 days Achieve a serum potassium level less than 5mEq/L
- Secondary Outcome Measures
Name Time Method Change in Acidosis (serum HCO3 levels) 15 days Changes in acidosis measured by blood parameters
Change in Endothelial function 15 days Improvement in endothelial function as measured by brachial artery ultrasound
Systematic inflammatory status using serum biomarkers 15 days Changes in inflammation measured by IL-6, CRP, Soluble urokinase-type Plasminogen Activator Receptor (suPAR), Monocyte Chemoattractant Protein-1 (MCP-1), Tumor Necrosis Factor Receptor (TNF-R), Fibroblast Growth Factor 23 (FGF23)
Changes in gut microbiota using stool collections 15 days We will perform 16S rRNA sequencing from stool samples to determine microbiota diversity and species determination.
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States