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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04727840
• Other study ID #: 2020P000975
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 15, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: January 2021
• Source: Brigham and Women's Hospital
• Contact: Lea Borgi, MD, MMSc
• Phone: 617-264-3053
• Email: lborgi[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 15, 2022
• Est. primary completion date: January 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalization of Serum Potassium level	Achieve a serum potassium level less than 5mEq/L	2 days
Secondary	Change in Endothelial function	Improvement in endothelial function as measured by brachial artery ultrasound	15 days
Secondary	Change in Acidosis (serum HCO3 levels)	Changes in acidosis measured by blood parameters	15 days
Secondary	Systematic inflammatory status using serum biomarkers	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)	15 days
Secondary	Changes in gut microbiota using stool collections	We will perform 16S rRNA sequencing from stool samples to determine microbiota diversity and species determination.	15 days