Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution

A Phase I Study to Evaluate the Short-term Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution With 30% Icodextrin and 10% Dextrose in Patients in Peritoneal Dialysis, on a Preliminary Basis

This study will evaluate the safety and tolerability profile of a dwell time (bath) of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose in patients with chronic kidney failure undergoing peritoneal dialysis

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: 30% icodextrin and 10% dextrose

Detailed Description

Phase I clinical trial which will include ten patients currently undergoing chronic peritoneal dialysis treatment. Patients will be hospitalized for the study. The study will consist of replacing conventional peritoneal dialysis solution with a sodium-free 500 ml solution with 30% icodextrin and 10% dextrose with a dwell time of 24 hours.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Juan B Ivey Miranda, MD; Phone Number: 22209 +52 5556276900; Email: betuel.ivey@gmail.com

Study Locations

• Mexico
  • Ciudad de México, Mexico, 06720
    • Recruiting
    • Hospital de Cardiología, Centro Médico Nacional Siglo XXI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients covered by the Mexican Social Security Department.
2. Adults over the age of eighteen.
3. Patients with chronic kidney failure undergoing replacement therapy with peritoneal dialysis.
4. Patients with a functional peritoneal dialysis catheter.
5. Patients undergoing peritoneal dialysis that was stable in the most recent month (ongoing peritoneal dialysis as an outpatient or ongoing cyclic peritoneal dialysis)
6. Patients who wish to participate and who sign the informed consent.
7. If the peritoneal dialysis catheter and the transfer line are compatible with the peritoneal dialysis bag that has a simple luer male connector.
8. If treating doctors consider their patient to be clinically euvolemic.
9. If patients have undergone a peritoneal equilibrium test and their dialysis prescription has not been changed since the test was carried out

Exclusion criteria:

1. Diabetes mellitus type 1 or uncontrolled diabetes (a1c hemoglobin greater than 8%).
2. Active infection.
3. Serum sodium prior to the study less than 130 mmol/l.
4. Serum bicarbonate prior to the study less than 18 mmol/l.
5. Patients who have been prescribed standard peritoneal dialysis who only use solutions with the lowest amount of dextrose
6. Hemoglobin less than 8 g/dl.
7. Active bleeding.
8. Patients prescribed peritoneal dialysis who use a 4.25% dextrose solution at least once a day.
9. Patients with a membrane defect or mechanical defect.
10. Diastolic dysfunction with an increase in filling pressure according to the echocardiogram.
11. Patients with active or suspected peritonitis according to the clinical criterion or their treating doctor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30% icodextrin and 10% dextrose; Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose	Drug: 30% icodextrin and 10% dextrose; Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety defined as the number serious adverse events related to the investigational product	Safety will be described based on the number of serious adverse events that are determined to be related to the investigational product	During the 24 hour dwell
Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain	Description of pain. Pain will be described in a scale from 0 to 4; 0 is no pain, 1 is mild pain, 2 is moderate pain, 3 is severe pain, and 4 is extreme pain. Pain will be assessed during infusion, then hourly during the 24 hour dwell, and during the draining	During the 24 hour dwell

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrafiltration	Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr dwell	During the 24 hour dwell
Sodium excretion with ultrafiltration	Sodium excretion with ultrafiltration will be calculated by multiplying the mL obtained during the draining after the 24hr dwell by the sodium concentration in a sample of peritoneal fluid	During the 24 hour dwell

Collaborators and Investigators

• Sponsor: Instituto Mexicano del Seguro Social
• Collaborators: Sequana Medical N.V.
• Investigators: Principal Investigator: Juan B Ivey Miranda, MD, Affiliated to Heart Failure Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2023
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Pharmaceutical Solutions; Dialysis Solutions; Icodextrin
• Other Study ID Numbers: R-2022-785-034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No