Concentration of Micafungin in the blood during continuous renal replacement therapy

PHARMACOKINETICS OF MICAFUNGIN DURING CONTINUOUS VENOVENOUS HEMOFILTRATION - MICA_HDF

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000904-14-AT

Enrollment

Registered

2012-03-29

Start date

2012-07-19

Completion date

Unknown

Last updated

2015-07-10

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

Conditions

Suspected or proven candida infection requiring parenteral antifungal therapy MedDRA version: 17.0 Level: LLT Classification code 10042941 Term: Systemic fungal infection NOS System Organ Class: 100000004862

Interventions

Trade Name: Mycamine Product Name: Mycamine Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: MICAFUNGIN CAS Number: 235114-32-6 Concentration unit: mg milligram(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 19 to 70 years Suspected or proven candia infection requiring parenteral antifungal therapy Continuous venovenous hemofiltration because of an acute renal failure 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 6 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4

Exclusion criteria

Exclusion criteria: Known history of hypersensitivity to echinocandins. An expected survival of less than three days. Known alcohol dependency, epilepsy, pregnancy or liver failure. Sooroesophagitis

Design outcomes

Primary

Measure	Time frame
Main Objective: Measuring pharmakokinetecs of micafungin during continuous renal replacement therapy;Secondary Objective: no secondary objectives;Primary end point(s): Pharmacokinetics of micafungin in CVVH(D)F: area under the curve (AUC), half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction.;Timepoint(s) of evaluation of this end point: 0, 2, 4, 6, 8, 24, 26, 28, 30, 32 and 48 hours after the first trial related infusion of Micafungin	—

Measure

Time frame

Main Objective: Measuring pharmakokinetecs of micafungin during continuous renal replacement therapy;Secondary Objective: no secondary objectives;Primary end point(s): Pharmacokinetics of micafungin in CVVH(D)F: area under the curve (AUC), half-life (t1/2), maximum and minimum plasma concentration (Cmax, Cmin), total body clearance (Cltot), hemofiltration clearance (ClHF), sieving coefficient and the elimination fraction.;Timepoint(s) of evaluation of this end point: 0, 2, 4, 6, 8, 24, 26, 28, 30, 32 and 48 hours after the first trial related infusion of Micafungin

—

Secondary

Measure	Time frame
Secondary end point(s): no secondary endpoints;Timepoint(s) of evaluation of this end point: no timepoints	—

Countries

Austria

Contacts

Public ContactFlorian Thalhammer

Medizinische Universität Wien

florian.thalhammer@meduniwien.ac.at00431404004440

Outcome results

None listed

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