Pharmakokinetik von lipid-formuliertem Amphotericin B unter Albumindialyse (Pharmacokinetics of lipid-formulated amphotericin B during albumin dialysis) - Amphotericin B in Albumin dialysis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003406-28-AT

Enrollment

Registered

2005-09-06

Start date

2005-09-07

Completion date

Unknown

Last updated

2022-05-16

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

Conditions

Plasma concentrations of lipidformulated amphotericin B will be measured in patients requiring treatment with lipid-formulated amphotericin B for systemic fungal infection (proven or suspected) and impaired renal function as well as albumin dialysis for cholestatic liver failure.

Interventions

Trade Name: Amphocil, AmBisome, Abelcet Product Name: Amphocil, AmBisome, Abelcet Product Code: ABCD / LAMB / ABLC Pharmaceutical Form: Concentrate for solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Indication for treatment with lipid-formulated amphotericin B Indication for albumin dialysis Need for arterial/venous line Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age below 18 years lacking indication / contraindicatio for lipidfromulate amphotericin B lacking indication / contraindication for albumin dialysis lacking consent pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine pharmacokinetics of lipid-formulated amphotericin B in patients undergoing albumindialysis;Secondary Objective: To provide dose recommendations for lipid-formulated amphotericin B administered to patients on albumin dialysis. To detect relvan pharmcokinetic differences between the threee amphotericin B lipid-formulations when administered to patients on albumin dialysis.;Primary end point(s): pharmacokinetics of lipidformulated amphotericin B: Cmax, Cmin, AUC, Kel, T 1/2, Vd, Clearance	—

Measure

Time frame

Main Objective: To determine pharmacokinetics of lipid-formulated amphotericin B in patients undergoing albumindialysis;Secondary Objective: To provide dose recommendations for lipid-formulated amphotericin B administered to patients on albumin dialysis. To detect relvan pharmcokinetic differences between the threee amphotericin B lipid-formulations when administered to patients on albumin dialysis.;Primary end point(s): pharmacokinetics of lipidformulated amphotericin B: Cmax, Cmin, AUC, Kel, T 1/2, Vd, Clearance

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026