Single Arm for Chronic Kidney Disease

Victoria Hospital, London Health Sciences Centre, London, Canada
Chronic Kidney DiseaseIcodextrin - Drug
Eligibility
18+
All Sexes

Study Summary

This trialis looking at how dialysis can safely remove sodium and fluids from kidney failure patients, reducing adverse outcomes. #dialysis #kidneyfailure #sodium #fluidremoval

Eligible Conditions
  • Chronic Kidney Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

11 Primary · 5 Secondary · Reporting Duration: Throughout the study visit - approximately 9 hours

Hour 9
Changes in hemodynamic stability (Blood Pressure)
Changes in hemodynamic stability (Finapres monitoring)
Changes in hemodynamic stability (Heart Rate)
Dialysate icodextrin biproducts
Number of participants with treatment related Adverse Events or Serious Adverse Events
Number of participants with treatment related Adverse Events or Serious Adverse Events.
Pain Assessment (Five-point Verbal Scale)
Pain Assessment (McGill Pain Questionnaire)
Participant hemodynamic stability and pain at infusion, dwell and drain
Potassium and bicarbonate removal
Serum Glucose monitoring and glucose absorption
Serum Icodextrin biproducts
Serum and dialysate icodextrin biproducts
Sodium Removal
Sodium Removal and Ultrafiltration results
Ultrafiltration Volume

Trial Safety

Phase-Based Safety

1 of 3

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1
Single Dose Olpasiran Hepatic Impairment
1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Single Arm
1 of 2
Intervention
1 of 2

Experimental Treatment

10 Total Participants · 2 Treatment Groups

Primary Treatment: Single Arm · No Placebo Group · Phase 1

Single Arm
Drug
Experimental Group · 1 Intervention: Icodextrin · Intervention Types: Drug
Intervention
Drug
Experimental Group · 1 Intervention: Icodextrin/Dextrose · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icodextrin
2010
Completed Phase 4
~180

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the study visit - approximately 9 hours

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
629 Previous Clinical Trials
403,967 Total Patients Enrolled
Christopher W McIntyre, MD/PHDPrincipal InvestigatorLondon Health Sciences Centre - Victoria Hospital
1 Previous Clinical Trials
37 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a working Tenckhoff catheter.
References

Frequently Asked Questions

What aspirations does this clinical investigation hope to achieve?

"This medical trial, with a duration of 9 hours, will assess Sodium Removal and Ultrafiltration results. Additionally, Serum Icodextrin biproducts (measuring efficacy), Serum and dialysate icodextrin biproducts (efficacy measurement) as well Potassium and bicarbonate removal (efficacy measurement) are secondary outcomes that need to be evaluated throughout the study period." - Anonymous Online Contributor

Unverified Answer

Are there vacancies for volunteers in this research endeavor?

"Affirmative. Clinicaltrials.gov displays that this medical trial, which was first listed on October 17th 2022, is searching for qualified participants. A total of 10 patients are needed from two different sites." - Anonymous Online Contributor

Unverified Answer

What is the scale of enrollment for this research trial?

"Correct. According to clinicaltrials.gov, this medical study is presently recruiting participants; it was first announced on October 17th 2022 and the most recent update occurred on the same day. The research requires 10 individuals from 2 locations." - Anonymous Online Contributor

Unverified Answer

Has the FDA sanctioned this Intervention?

"The safety of Intervention is tentatively rated at 1, due to the nature of this Phase 1 trial. This means there are limited confirmations regarding its efficacy and safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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