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CLEARTOX: Development of an innovative haemodialysis method to improve dialytic clearance of protein-bound uraemic toxins

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510406-41-00
Acronym
69HCL23_0031
Enrollment
12
Registered
2024-11-12
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hemodialysis patients (for more than 3 months) with no residual diuresis (<100 mL/day).

Brief summary

Clearance of p-Cresyl sulfate during hemodialysis. Dialysis clearance is defined as follows: Clairance = Qd X (C dialysate/C arterial) Calculated over 240 minutes with Qd corresponding to dialysate flow rate, C dialysate uremic toxin concentration in dialysate, C arterial uremic toxin concentration in blood taken from the arterial port of the dialyzer.

Detailed description

The fraction of p-CS reduction during the hemodialysis session. The reduction fraction (RF) will be calculated according to the formula: RF (%) = ( Concentration (t=0 min) - Concentration (t=240 min ))/Concentration (t= 0 min), Clearance and reduction fraction (over 240 minutes) of other protein-bound uremic toxins during the hemodialysis session: indoxyl sulfate, hippuric acid, p-cresyl glucuronide, 3-indole acetic acid, uric acid and 3-carboxy-4-methyl-5propyl-furanpro-pionic acid., Tolerance: % of patients with at least one of the following adverse events: nausea, vomiting or headache during the session., Safety: % of patients with one of the following events: triglyceridemia > 4 g/L or 4.6 mmol/L at the end of the session, alteration in liver balance (ALT, ASAT, gamma GT, PAL, free and conjugated bilirubin) or significant hemolysis during follow-up., Comparison of plasma concentration of medium-chain fatty acids (octanoate and decanoate) between start and end of infusion.

Interventions

Sponsors

Hospices Civils De Lyon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Clearance of p-Cresyl sulfate during hemodialysis. Dialysis clearance is defined as follows: Clairance = Qd X (C dialysate/C arterial) Calculated over 240 minutes with Qd corresponding to dialysate flow rate, C dialysate uremic toxin concentration in dialysate, C arterial uremic toxin concentration in blood taken from the arterial port of the dialyzer.

Secondary

MeasureTime frame
The fraction of p-CS reduction during the hemodialysis session. The reduction fraction (RF) will be calculated according to the formula: RF (%) = ( Concentration (t=0 min) - Concentration (t=240 min ))/Concentration (t= 0 min), Clearance and reduction fraction (over 240 minutes) of other protein-bound uremic toxins during the hemodialysis session: indoxyl sulfate, hippuric acid, p-cresyl glucuronide, 3-indole acetic acid, uric acid and 3-carboxy-4-methyl-5propyl-furanpro-pionic acid., Tolerance: % of patients with at least one of the following adverse events: nausea, vomiting or headache during the session., Safety: % of patients with one of the following events: triglyceridemia > 4 g/L or 4.6 mmol/L at the end of the session, alteration in liver balance (ALT, ASAT, gamma GT, PAL, free and conjugated bilirubin) or significant hemolysis during follow-up., Comparison of plasma concentration of medium-chain fatty acids (octanoate and decanoate) between start and end of infusion.

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026