PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE

PHARMACOKINETICS OF ORAL SPIRONOLACTONE IN CHILDREN UP TO 2 YEARS OF AGE - Pharmacokinetics of spironolactone in children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001189-40-EE

Enrollment

Registered

2014-10-14

Start date

Unknown

Completion date

Unknown

Last updated

2017-10-02

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

Conditions

cardiac failure, ascites and/or oedema MedDRA version: 17.0 Level: HLGT Classification code 10010394 Term: Congenital cardiac disorders System Organ Class: 10007541 - Cardiac disorders MedDRA version: 17.0 Level: PT Classification code 10049630 Term: Oedema due to renal disease System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 17.0 Level: LLT Classification code 10030103 Term: Oedema generalized System Organ Class: 10018065 - General disorders

Interventions

Product Name: Spironolactonum micronisatum Product Code: Spironolactonum micronisatum Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: Spironolactonum Other descriptive name: SPIRO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Age 35+0 weeks of gestation up to two years of age 2. Clinical need for spironolactone treatment due to heart failure, ascites, oedema 3. Clinical need for an arterial, central venous or venous catheter 4. Admission to study units 5. Informed consent by the parents or by the legitimate representative of the child. Are the trial subjects under 18? yes Number of subjects for this age range: 27 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Acute renal insufficiency, oligoanuria diuresis 100 mcmol/L 2. Addison's disease or other conditions associated with hyperkalemia 3. Hyperkalemia >5.5 mmol/l 4. Hyponatraemia <130.0 mmol/l 5. Hypersensitivity to spironolactone 6. Concomitant use of potassium sparing diuretics

Design outcomes

Primary

Measure	Time frame
Main Objective: Aims of the study - To describe PK profile of spironolactone in children up to two years of age with cardiac failure, ascites and/or oedema - To describe PK parameters of the main metabolites of spironolactone (7 alpha- thiomethylspironolactone and canrenone) in children up to two years of age - To correlate plasma PK profiles of spironolactone with predefined clinical efficacy measures in children up to two years of age with cardiac failure, ascites and/or oedema ;Secondary Objective: • To describe PK profile of spironolactone in children up to two years of age with cardiac failure, ascites and/or oedema; • To describe PK parameters of the main metabolites of spironolactone (7 alpha- thiomethylspironolactone and canrenone) in children up to two years of age; • To correlate plasma PK profiles of spironolactone with predefined clinical efficacy measures in children up to two years of age with cardiac failure, ascites and/or oedema; • To assess the safety profiles of oral spironolactone in children up to two years of age. ;Primary end point(s): • A noncompartmental model of disposition of spironolactone and its main metabolites o CL, Vd, AUC, Cmax, Tmax ;Timepoint(s) of evaluation of this end point: Blood samples for spironolactone and main metabolites plasma concentration measurements will be collected before and in the following time-points after the study dose of the drug: 30 min, 60 min, 1,5h, 4h, 8h, 12h, 23h and also 46h and 72h after study dose if feasible or from the leftovers of regular blood analyses drawn after the 23 hour post dose.	—

Measure

Time frame

Main Objective: Aims of the study - To describe PK profile of spironolactone in children up to two years of age with cardiac failure, ascites and/or oedema - To describe PK parameters of the main metabolites of spironolactone (7 alpha- thiomethylspironolactone and canrenone) in children up to two years of age - To correlate plasma PK profiles of spironolactone with predefined clinical efficacy measures in children up to two years of age with cardiac failure, ascites and/or oedema ;Secondary Objective: • To describe PK profile of spironolactone in children up to two years of age with cardiac failure, ascites and/or oedema; • To describe PK parameters of the main metabolites of spironolactone (7 alpha- thiomethylspironolactone and canrenone) in children up to two years of age; • To correlate plasma PK profiles of spironolactone with predefined clinical efficacy measures in children up to two years of age with cardiac failure, ascites and/or oedema; • To assess the safety profiles of oral spironolactone in children up to two years of age. ;Primary end point(s): • A noncompartmental model of disposition of spironolactone and its main metabolites o CL, Vd, AUC, Cmax, Tmax ;Timepoint(s) of evaluation of this end point: Blood samples for spironolactone and main metabolites plasma concentration measurements will be collected before and in the following time-points after the study dose of the drug: 30 min, 60 min, 1,5h, 4h, 8h, 12h, 23h and also 46h and 72h after study dose if feasible or from the leftovers of regular blood analyses drawn after the 23 hour post dose.

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Estonia

Contacts

Public ContactNeonatal ward

Tartu University Hospital, Childrens Clinic

heili.varendi@kliinikum.ee+3725088878

Outcome results

None listed

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