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

NCT04727840 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-02-01

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases
  • Hyperkalemia

Interventions

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.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Lea Borgi, MD, MMSc · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2022-01-15
Completion
2022-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727840 on ClinicalTrials.gov