Clinical trial NCT04727840: Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)
Official title: Combined Dietary Intervention in Hyperkalemic CKD Patients With Potassium Binder (With Hyperkalemia) (DiPo Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Kidney Diseases
Hyperkalemia
Keywords: Nutrition
Kidney Disease
Potassium binder
Sodium zirconium cyclosilicate
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study in 20 patients
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Normalization of Serum Potassium level
timeFrame: 2 days
Secondary outcomes:
measure: Change in Endothelial function
timeFrame: 15 days
measure: Change in Acidosis (serum HCO3 levels)
timeFrame: 15 days
measure: Systematic inflammatory status using serum biomarkers
timeFrame: 15 days
measure: Changes in gut microbiota using stool collections
timeFrame: 15 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Lea Borgi, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References: