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

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
30% icodextrin and 10% dextrose
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion criteria: 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.

Sites / Locations

  • Hospital de Cardiología, Centro Médico Nacional Siglo XXIRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

30% icodextrin and 10% dextrose

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Ultrafiltration
Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr 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

Full Information

First Posted
February 7, 2023
Last Updated
March 24, 2023
Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Sequana Medical N.V.
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1. Study Identification

Unique Protocol Identification Number
NCT05780086
Brief Title
Safety of and Tolerability to a Sodium-free Peritoneal Dialysis Solution
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
Collaborators
Sequana Medical N.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
30% icodextrin and 10% dextrose
Arm Type
Experimental
Arm Description
Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose
Intervention Type
Drug
Intervention Name(s)
30% icodextrin and 10% dextrose
Intervention Description
Dwell time of 24 hours using a 500 ml sodium-free peritoneal dialysis solution based on 30% icodextrin and 10% dextrose
Primary Outcome Measure Information:
Title
Safety defined as the number serious adverse events related to the investigational product
Description
Safety will be described based on the number of serious adverse events that are determined to be related to the investigational product
Time Frame
During the 24 hour dwell
Title
Tolerability defined as pain in a scale from 0 to 4 during infusion, dwell, and drain
Description
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
Time Frame
During the 24 hour dwell
Secondary Outcome Measure Information:
Title
Ultrafiltration
Description
Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr dwell
Time Frame
During the 24 hour dwell
Title
Sodium excretion with ultrafiltration
Description
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
Time Frame
During the 24 hour dwell

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan B Ivey Miranda, MD
Phone
+52 5556276900
Ext
22209
Email
betuel.ivey@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan B Ivey Miranda, MD
Organizational Affiliation
Affiliated to Heart Failure Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Cardiología, Centro Médico Nacional Siglo XXI
City
Ciudad de México
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan B Ivey-Miranda, MD
Phone
+52 5543683768
Email
betuel.ivey@gmail.com

12. IPD Sharing Statement

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

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