Clinical trial NCT05185999: Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Kidney Failure
Keywords: Peritoneal Dialysis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, Open Label, Phase 1 Interventional study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Number of participants with treatment related Adverse Events or Serious Adverse Events.
timeFrame: Throughout the study visit - approximately 9 hours
measure: Changes in hemodynamic stability (Blood Pressure)
timeFrame: Throughout the study visit - approximately 9 hours
measure: Changes in hemodynamic stability (Heart Rate)
timeFrame: Throughout the study visit - approximately 9 hours
measure: Changes in hemodynamic stability (Finapres monitoring)
timeFrame: Throughout the study visit - approximately 9 hours
measure: Sodium Removal
timeFrame: Throughout the study visit - approximately 9 hours
measure: Pain Assessment (Five-point Verbal Scale)
timeFrame: Throughout the study visit - approximately 9 hours
measure: Pain Assessment (McGill Pain Questionnaire)
timeFrame: Throughout the study visit - approximately 9 hours
measure: Ultrafiltration Volume
timeFrame: Throughout the study visit - approximately 9 hours
Secondary outcomes:
measure: Serum Glucose monitoring and glucose absorption
timeFrame: Throughout the study visit - approximately 9 hours
measure: Dialysate icodextrin biproducts
timeFrame: Throughout the study visit - approximately 9 hours
measure: Serum Icodextrin biproducts
timeFrame: Throughout the study visit - approximately 9 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital, London Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: Westmount Kidney Care Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre - Victoria Hospital
name: Christopher W McIntyre, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: