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

NCT04727840 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 2020P000975
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Hyperkalemia

Keywords

Nutrition; Kidney Disease; Potassium binder; Sodium zirconium cyclosilicate

Outcome Measures

Primary Outcomes (1)

• Normalization of Serum Potassium level

  Achieve a serum potassium level less than 5mEq/L

  2 days

Secondary Outcomes (4)

• Change in Endothelial function

  15 days

• Change in Acidosis (serum HCO3 levels)

  15 days

• Systematic inflammatory status using serum biomarkers

  15 days

• Changes in gut microbiota using stool collections

  15 days

Study Arms (1)

Intervention

OTHER

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

Interventions

Sodium Zirconium Cyclosilicate Oral Product DRUG

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperkalemia; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Lea Borgi, MD, MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Borgi, MD, MMSc

CONTACT

617-264-3053; lborgi@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Program Director, BWH/MGH Nephrology Fellowship Program Associate Physician, Renal Division, Brigham and Women's Hospital Instructor in Medicine, Harvard Medical School

Model Details: Pilot study in 20 patients

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 27, 2021
• Study Start: March 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)