NCT05780086

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-03
• Primary completion: 2023-08-30
• Completion: 2023-12-30
• First posted: 2023-03-22
• Last updated: 2023-03-28

Locations

1 site across 1 country: Mexico