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

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780086
• Other study ID #: R-2022-785-034
• Status: Recruiting
• Phase: Phase 1
• Start date: February 3, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Instituto Mexicano del Seguro Social
• Contact: Juan B Ivey Miranda, MD
• Phone: +52 5556276900
• Email: betuel.ivey[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital de Cardiología, Centro Médico Nacional Siglo XXI	Ciudad de México

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social	Sequana Medical N.V.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ultrafiltration	Total volume ultrafiltration as determined by the mL obtained during the draining after the 24hr dwell	During the 24 hour dwell
Secondary	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