Saving residual kidney function among haemodialysis patients receiving irbesartan - a double blind randomised study - SAFIR

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-001267-11-DK

Enrollment

Registered

2008-08-12

Start date

2008-09-29

Completion date

Unknown

Last updated

2014-03-10

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

Conditions

We want to investigate if an angiotensin II antagonist (irbesartan) has beneficial effects regarding residual kidney function and heart/vessels among haemodialysis patients. MedDRA version: 9.1 Level: LLT Classification code 10049415 Term: Renin-angiotensin system inhibition

Interventions

Trade Name: Aprovel Pharmaceutical Form: Tablet INN or Proposed INN: IRBESARTAN CAS Number: 138402116 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 150-300 Pharma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Haemodialysis patient Haemodialysis for maximum 1 year Urine volume > 300 ml/24 hours Informed consent 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: Known allergy to angiotensin II antagonist or ACE-inhibitor Acute myocardial infarction in the preceding 3 months Ejection fraction < 30 % Systolic blood pressure < 110 mm Hg

Design outcomes

Primary

Measure	Time frame
Main Objective: Does an angiotensin II antagonist (irbesartan) save residual kidney function and protect heart and vessels?;Secondary Objective: Quality of Life will be assessed by a questionnaire.;Primary end point(s): Reduced decline in GFR estimated by 24 hours urine collections and creatinine/urea clearances as well as urine volume. Status quo or reduced arterial stiffness measured by applanation tonometry. Status quo or reduced left ventricular hypertrophy assessed by echocardiography. Altered intradialytic haemodynamics.	—

Measure

Time frame

Main Objective: Does an angiotensin II antagonist (irbesartan) save residual kidney function and protect heart and vessels?;Secondary Objective: Quality of Life will be assessed by a questionnaire.;Primary end point(s): Reduced decline in GFR estimated by 24 hours urine collections and creatinine/urea clearances as well as urine volume. Status quo or reduced arterial stiffness measured by applanation tonometry. Status quo or reduced left ventricular hypertrophy assessed by echocardiography. Altered intradialytic haemodynamics.

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Countries

Denmark

Outcome results

None listed

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