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

NCT05185999 | Completed Phase 1

• 1 other identifier: 119910
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Failure

Keywords

Peritoneal Dialysis

Outcome Measures

Primary Outcomes (8)

• 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.

  Throughout the study visit - approximately 9 hours

• 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.

  Throughout the study visit - approximately 9 hours

• 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.

  Throughout the study visit - approximately 9 hours

• 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)

  Throughout the study visit - approximately 9 hours

• 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.

  Throughout the study visit - approximately 9 hours

• 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.

  Throughout the study visit - approximately 9 hours

• 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.

  Throughout the study visit - approximately 9 hours

• Ultrafiltration Volume

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

  Throughout the study visit - approximately 9 hours

Secondary Outcomes (3)

• Serum Glucose monitoring and glucose absorption

  Throughout the study visit - approximately 9 hours

• Dialysate icodextrin biproducts

  Throughout the study visit - approximately 9 hours

• Serum Icodextrin biproducts

  Throughout the study visit - approximately 9 hours

Study Arms (1)

Intervention

EXPERIMENTAL

Intraperitoneal infusion with 500 mL of sodium-free 30% Icodextrin/ 10% Dextrose solution

Drug: Icodextrin/Dextrose

Interventions

Icodextrin/Dextrose DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (2)

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Westmount Kidney Care Centre

London, Ontario, N6K 1M6, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Icodextrin; Glucose

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Hexoses; Monosaccharides; Sugars

Study Officials

• Christopher W McIntyre, MD/PHD

  London Health Sciences Centre - Victoria Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-arm, Open Label, Phase 1 Interventional study

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 11, 2022
• Study Start: October 17, 2022
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)