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

NCT05780086 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-03-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sequana Medical N.V.

    collaborator INDUSTRY

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Principal Investigators

  • Juan B Ivey Miranda, MD · Affiliated to Heart Failure Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2023-08-30
Completion
2023-12-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05780086 on ClinicalTrials.gov