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

NCT05780086 | Unknown Phase 1 DMC

• 1 other identifier: R-2022-785-034
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Ultrafiltration

  During the 24 hour dwell

• Sodium excretion with ultrafiltration

  During the 24 hour dwell

Study Arms (1)

30% icodextrin and 10% dextrose

EXPERIMENTAL

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

Interventions

30% icodextrin and 10% dextrose DRUG

Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose

30% icodextrin and 10% dextrose

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead
• Sequana Medical N.V.: collaborator

Study Sites (1)

Hospital de Cardiología, Centro Médico Nacional Siglo XXI

Mexico City, 06720, Mexico

RECRUITING

Related Publications (1)

• Asher JL, Ivey-Miranda JB, Maulion C, Cox ZL, Borges-Vela JA, Mendoza-Zavala GH, Cigarroa-Lopez JA, Silva-Rueda RI, Revilla-Monsalve C, Moreno-Villagomez J, Ramos-Mastache D, Goedje O, Crosbie I, McIntyre C, Finkelstein F, Turner JM, Testani JM, Rao VS. Development of a Novel Intraperitoneal Icodextrin/Dextrose Solution for Enhanced Sodium Removal. Kidney Med. 2024 Nov 16;7(1):100938. doi: 10.1016/j.xkme.2024.100938. eCollection 2025 Jan.

  PMID: 39790231 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Icodextrin; Glucose

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; 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

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Hexoses; Monosaccharides; Sugars

Study Officials

• Juan B Ivey Miranda, MD

  Affiliated to Heart Failure Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan B Ivey Miranda, MD

CONTACT

+52 5556276900; betuel.ivey@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Education at Hospital de Cardiologia

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: March 22, 2023
• Study Start: February 3, 2023
• Primary Completion: August 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Locations

ME (1)