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

119910

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.

2022-10-17

2023-10-20

2023-10-20

Completed

Early phase I

10

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm, Open Label, Phase 1 Interventional study', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}

2024-01-29