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Theranova Dialyzer for Kidney Failure

N/A

Recruiting

Led By Christopher McIntyre, MBBS DM

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

Must be on hemodialysis for at least 3 months

Age ≥18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between weeks 1 & 4 and repeated during week 28

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand and address the symptoms that patients on dialysis experience. Researchers will use a platform called LEVIL to track patient-reported symptoms over 28 weeks of treatment. The study will

Who is the study for?

This trial is for adults over 18 who have been on hemodialysis for at least three months due to chronic kidney failure. They must be following a conventional dialysis schedule of three times per week and be willing to report their symptoms using the LEVIL app.

What is being tested?

The study is testing a new Theranova Dialyzer against the current standard one. It aims to see if the new dialyzer, which removes larger toxins from blood, can reduce symptom burden in patients undergoing up to three hemodialysis treatments weekly for 28 weeks.

What are the potential side effects?

While specific side effects are not listed, potential ones may relate to changes in how toxins are removed during dialysis with the new Theranova Dialyizer, possibly affecting patient-reported symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on hemodialysis for at least 3 months.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between weeks 1 & 4 and repeated during week 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between weeks 1 & 4 and repeated during week 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and between weeks 1 & 4 and repeated during week 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.

Secondary study objectives

Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition.

Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects dialysis recovery time compared to high-flux dialysis membrane.

Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects sexual desire

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: Patients receiving HemodialysisExperimental Treatment1 Intervention

A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Theranova Dialyzer

2019

N/A

~90

0 / 2Eligibility criteria met