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Peritoneal Ultrafiltration for Chronic Kidney Failure (IPUF-HD Trial)

Phase 2
Recruiting
Led By Christopher W. McIntyre, MD, PhD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 vs 4, week 1 vs 6
Awards & highlights
No Placebo-Only Group

Summary

This trialstudies if additional sodium removal between hemodialysis sessions can improve outcomes for kidney disease patients.

Who is the study for?
This trial is for adults over 18 who are on hemodialysis up to three times a week for chronic kidney failure but can't reach their prescribed dry weight. They should gain at least 4% of their dry weight between sessions and be able to consent. It's not for those with conditions that rule out peritoneal dialysis or MRI, uncontrolled diabetes, active infections, non-compliance with hemodialysis, or very low sodium levels.
What is being tested?
The study tests if extra peritoneal dialysis using a dextrose solution can better remove excess sodium from tissues in-between regular hemodialysis sessions. Ten patients will have this additional treatment twice weekly for three weeks and undergo leg MRIs to measure tissue sodium before and after the study.
What are the potential side effects?
Potential side effects may include discomfort or infection at the catheter insertion site, changes in blood pressure during the procedure, shifts in blood sugar levels due to dextrose solution used in peritoneal ultrafiltration, and possible adverse reactions related to MRI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 vs 4, week 1 vs 5-6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 vs 4, week 1 vs 5-6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events
Skin sodium concentration
Secondary study objectives
Body Weight Changes
Home blood pressure
Infusion pain
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Interdialytic peritoneal ultrafiltrationExperimental Treatment1 Intervention
Will receive incremental interdialytic peritoneal ultrafiltration with a 10% dextrose solution, twice a week for three consecutive weeks

Find a Location

Who is running the clinical trial?

Sequana Medical N.V.Industry Sponsor
15 Previous Clinical Trials
814 Total Patients Enrolled
Lawson Health Research InstituteLead Sponsor
683 Previous Clinical Trials
431,410 Total Patients Enrolled
Christopher W. McIntyre, MD, PhDPrincipal InvestigatorLawson Research Institute
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Interdialytic peritoneal ultrafiltration with 10% dextrose solution Clinical Trial Eligibility Overview. Trial Name: NCT04603014 — Phase 2
Hemodialysis Research Study Groups: Interdialytic peritoneal ultrafiltration
Hemodialysis Clinical Trial 2023: Interdialytic peritoneal ultrafiltration with 10% dextrose solution Highlights & Side Effects. Trial Name: NCT04603014 — Phase 2
Interdialytic peritoneal ultrafiltration with 10% dextrose solution 2023 Treatment Timeline for Medical Study. Trial Name: NCT04603014 — Phase 2
~2 spots leftby Dec 2025
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