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

• Status: Not yet recruiting
• Trial end date: 2022-01-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital

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