Status:
COMPLETED
Icodextrin Study to Test Short-Term Safety, Tolerability and Preliminary Efficacy of Sodium-Free Solution in PD Patients
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Chronic Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 consi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05185999
Start Date
October 17 2022
End Date
October 20 2023
Last Update
January 29 2024
Active Locations (2)
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1
Victoria Hospital, London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
2
Westmount Kidney Care Centre
London, Ontario, Canada, N6K 1M6