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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
Inability to consistently achieve dry weight with the current treatment schedule
Need for additional HD treatments to achieve prescribed dry weight
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 vs week 4, week 1 vs 5-6
Awards & highlights

IPUF-HD Trial 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.Check my eligibility
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.See study design
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.

IPUF-HD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can't reach my target weight with my current treatment.
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I need more dialysis sessions to reach my target weight.
Select...
I undergo hemodialysis up to three times a week.
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I am 18 years old or older.

IPUF-HD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of all study treatments
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of all study treatments for reporting.

Treatment Details

Study Objectives

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

IPUF-HD 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?

Lawson Health Research InstituteLead Sponsor
655 Previous Clinical Trials
413,329 Total Patients Enrolled
Sequana Medical N.V.Industry Sponsor
15 Previous Clinical Trials
814 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
Kidney Disease Research Study Groups: Interdialytic peritoneal ultrafiltration
Kidney Disease 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Jun 2024