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Chronic Kidney FailurePhase 1NCT05185999

Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients

A Phase 1 study testing Icodextrin/Dextrose in people with Chronic Kidney Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with kidney failure rely on dialysis for sodium and fluid removal. The importance of a sodium and fluid balance in patients with kidney disease is very important. Excess volume has been consistently associated with cardiovascular morbidity and mortality. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Failure
What is being tested?
Icodextrin/Dextrose
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesCanada
Study dates
17 Oct 2022to 20 Oct 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Functioning Tenckhoff catheter
  • Stable PD prescription regimen (continuous ambulatory PD or automated PD) for the past month
  • Age 18 years or older
  • Willing and able to provide informed consent
  • Able to Speak and Read English

Who cannot join

  • Type 1 or uncontrolled diabetes mellitus
  • Active infections
  • Pre-study serum sodium <130 mmol/L
  • Serum bicarbonate < 18mmol/L
  • Patients with standard PD prescriptions relying exclusively on lowest glucose containing fluid
  • Allergy to starch-based polymers (e.g. corn starch) and/or icodextrin
Show all 10Show fewer
  • Intolerance to maltose or isomaltose
  • Glycogen storage disease
  • Uncorrectable mechanical defects that prevent effective PD or increase the risk of infection
  • Documented loss of peritoneal function or extensive adhesions that compromise peritoneal function

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Victoria Hospital, London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Westmount Kidney Care Centre

    London, Ontario, N6K 1M6

Other trials in Canada

About this study

Official title: A Phase 1 Interventional Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Intraperitoneal 30% Icodextrin/10% Dextrose Solution in Peritoneal Dialysis Patients

Patients with kidney failure rely on dialysis for sodium and fluid removal. The importance of a sodium and fluid balance in patients with kidney disease is very important. Excess volume has been consistently associated with cardiovascular morbidity and mortality.

Many peritoneal dialysis (PD) patients need large volumes of dextrose or Icodextrin based solutions to achieve fluid removal. Commonly used PD solutions also have high sodium concentrations to limit sugar absorption. These PD fluids can reduce the amount of sodium removed and may eventually lead to water retention over time with possible adverse outcomes.

This research study is being conducted to determine if a single eight-hour dwell of intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution is safe, tolerable and effective in achieving sodium and volume removal in PD patients.

Read the detailed description

This study is a phase 1 interventional study in Peritoneal Dialysis Patients. Investigators will recruit 10 participants. This study involves one visit at the London Health Sciences Centre University Hospital lasting approximately 9 hours.

Study participants will receive one in-center PD dwell, consisting of peritoneal instillation of a sodium-free 30% Icodextrin/10% dextrose solution via their Tenckhoff catheter; the solution will be dwelling in the study participant's peritoneal cavity for a maximum of 8 hours as tolerated, at the end of which the solution will be drained.

Participants will be monitored during administration of the study solution, during dwell and up to one hour after the Peritoneal Dialysis fluid is drained.

Study participants will also undergo:

  • Clinical blood pressure and heart rate monitoring: baseline + every 15 minutes for the first two hours; then every 30 minutes up until 1 hour post complete peritoneal solution drain
  • Continuous Finapress hemodynamic monitoring (until 1 hour post peritoneal solution drain)
  • Pain Monitoring throughout the study visit (Five point verbal scale and McGill Pain Questionnaire)
  • Blood collection: baseline, 1, 2, 4, 8 hours into the dwell and 1 hour after the end of drain
  • Peritoneal dialysate collection: 1, 2, 4, 8 hours into the dwell
  • Urine collection throughout visit.
Being tested
Icodextrin/Dextrose
Keywords
Peritoneal Dialysis
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Icodextrin/DextroseDrug

    Single 8 hour dwell of a 500mL intraperitoneal sodium-free 30% Icodextrin / 10% Dextrose solution

Study groups in NCT05185999
Study groupRoleWhat they receive
InterventionExperimentalIntraperitoneal infusion with 500 mL of sodium-free 30% Icodextrin/ 10% Dextrose solution
Receives: Drug: Icodextrin/Dextrose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment related Adverse Events or Serious Adverse Events.

    Adverse Events and Serious Adverse Events will help determine the safety of the intraperitoneal solution. Change in symptoms from baseline.

    Measured: Throughout the study visit - approximately 9 hours

  2. Changes in hemodynamic stability (Blood Pressure)

    This will determine participant tolerability of the treatment. Systolic and Diastolic blood pressure (mm/Hg) will be measured throughout the study visit at baseline, every 15 minutes for 2 hours, then every 30 minutes until 1 hour after solution drain is complete.

    If the systolic or diastolic blood pressure changes more then 40 mmHg or more at any time point the study physician will be consulted for direction.

    Measured: Throughout the study visit - approximately 9 hours

  3. Changes in hemodynamic stability (Heart Rate)

    This will determine participant tolerability of the treatment. We will monitor heart rate (bpm) at baseline, every 15 minutes for 2 hours, then every 30 minutes until 1 hour after solution drain is complete.

    If heart rate is less then 50 beats per minute or greater then 120 beats per minute the study physician will be alerted.

    Measured: Throughout the study visit - approximately 9 hours

  4. Changes in hemodynamic stability (Finapres monitoring)

    This will determine tolerability of the treatment. Hemodynamic monitoring using Finapres (finger-cuff to detect beat-to-beat changes) Hemodynamic variables such as pulse rate, blood pressure, stroke volume, cardiac output, and total peripheral resistance are derived. (for post hoc observational analysis only)

    Measured: Throughout the study visit - approximately 9 hours

  5. Sodium Removal

    This will measure the efficacy of the treatment. Serum sodium (mmol/L) levels will be drawn at baseline, 1, 2, 4, 8 and 9 hours and sent to the lab for analysis.

    Measured: Throughout the study visit - approximately 9 hours

  6. Pain Assessment (Five-point Verbal Scale)

    This pain assessment will determine tolerability of the treatment. Five-point Verbal Scale (0-no pain, 1=mild pain, 2=moderate pain, 3=severe pain, 4=very severe pain)

    We will complete the Five-point Verbal Scale at the following time points:

    • start of infusion at 1, 3, and 5 minutes after start of infusion and at end of infusion of the Icodextrin/Dextrose solution
    • 15, 30 minutes into dwell, hourly during dwell and at the end of dwell of the Icodextrin/Dextrose solution
    • start of drain, 5 minutes into drain and end of drain of the Icodextrin/Dextrose solution If Five-Point verbal scale >3 for two consecutive readings and if pain exceeds individual tolerability, fluid will be drained and the study physician will be alerted.

    Measured: Throughout the study visit - approximately 9 hours

  7. Pain Assessment (McGill Pain Questionnaire)

    This pain assessment will determine tolerability of the treatment. McGill Pain Questionnaire (MPQ) 30 minutes into dwell of the Icodextrin/Dextrose solution The MPQ explores the multi-dimensional nature of pain.

    Measured: Throughout the study visit - approximately 9 hours

  8. Ultrafiltration Volume

    This will measure the efficacy of the treatment. Ultrafiltrate will be measured in litres post drain.

    Measured: Throughout the study visit - approximately 9 hours

Secondary outcomes (3)

  1. Serum Glucose monitoring and glucose absorption

    This will measure glucose (mmol/L) levels will be drawn at baseline, 1, 2, 4, 8 and 9 hours and sent to the lab for analysis.

    Measured: Throughout the study visit - approximately 9 hours

  2. Dialysate icodextrin biproducts

    This will measure the efficacy of the treatment. A 15 ml sample of peritoneal effluent will be collected at 1, 2, 4 and 8 hours in to dwell. This sample will be sent to the lab for the analysis of dialysate Icodextrin biproducts.

    Measured: Throughout the study visit - approximately 9 hours

  3. Serum Icodextrin biproducts

    This will measure the efficacy of the treatment. Serum will be collected at baseline, 1, 2, 4 and 8 and 9 hours and sent to lab for analysis of Icodextrin biproducts.

    Measured: Throughout the study visit - approximately 9 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start17 Oct 2022
  3. Primary completion20 Oct 2023
  4. Study completion20 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Single-arm, Open Label, Phase 1 Interventional study
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05185999
Sponsor's protocol ID
119910
Status last verified
Jan 2024
First submitted
6 Dec 2021
Last updated
29 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Icodextrin/Dextrose in people with Chronic Kidney Failure, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment related Adverse Events or Serious Adverse Events. (time frame: Throughout the study visit - approximately 9 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05185999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.

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