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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Diseases; Hyperkalemia
• Intervention / Treatment: Drug: Sodium Zirconium Cyclosilicate Oral Product

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Lea Borgi, MD, MMSc; Phone Number: 617-264-3053; Email: lborgi@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normalization of Serum Potassium level	Achieve a serum potassium level less than 5mEq/L	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Endothelial function	Improvement in endothelial function as measured by brachial artery ultrasound	15 days
Change in Acidosis (serum HCO3 levels)	Changes in acidosis measured by blood parameters	15 days
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
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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 15, 2021
• Primary Completion (ANTICIPATED): January 15, 2022
• Study Completion (ANTICIPATED): January 15, 2022

Study Registration Dates

• First Submitted: January 15, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (ACTUAL): January 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Nutrition; Kidney Disease; Potassium binder; Sodium zirconium cyclosilicate
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Water-Electrolyte Imbalance; Kidney Diseases; Renal Insufficiency, Chronic; Hyperkalemia
• Other Study ID Numbers: 2020P000975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No