Randomised trial on combined effects of dual blockade of the renin angiotensin system and phosphate binding in diabetic and non-diabetic patients with impaired renal function. - DUAL study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004099-26-DK

Enrollment

Unknown

Registered

2009-07-22

Start date

2009-12-10

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

decreased renal function (CKD II-IV), creatinin clearance 15-90 ml/min MedDRA version: 18.0 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 18.0 Level: LLT Classification code 10013231 Term: Disorder kidney System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: fosrenol Pharmaceutical Form: Chewable tablet INN or Proposed INN: lanthanumcarbonat Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Trade Name: c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Cr EDTA clearence 25-70 ml/min proteinuria > 0,5 g/day s-potassium 2 years CRP, fibrinogen, LDH, ALAT, bilirubin below 2 times upper normal range (reference values) 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: former dialysis og transplanted patient uncontrolled hypertension arythmia or ischemic heart disease chronic infection pregnancy or no use of safe anticonception BMI>40 diabtes with HbA1c>10% immunosuppressiv therapy chronic cough allergy to any of the used study medications proteinuria>10g/day obstructive urinary tract disease ionized s-calcium > 1,4 mmol/l or s-phosphate < 0,8,mmol/l participation inother interventional studies

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of dual blockade of the renin-angiotensin system (enalapril plus irbesartan) compared to monoblockade (enalapril alone) to preserve kidney function. To evaluate whether early intervention with non-calcium phosphate binder prevents vascular calcification.;Secondary Objective: To compare the changes in markers of vascular calcification(crp, PTH, Fetuin-A, lipids, insulin, FGF-23, MSCT) and decreased kidney function (Cr-EDTA and albuminuria) ;Primary end point(s): This study is powered to evaluate wheter the treatment modalities 1. prevents loss of kidney function measured by Cr EDTA clearence 2. reduces proteinuria	—

Measure

Time frame

Main Objective: To evaluate the effect of dual blockade of the renin-angiotensin system (enalapril plus irbesartan) compared to monoblockade (enalapril alone) to preserve kidney function. To evaluate whether early intervention with non-calcium phosphate binder prevents vascular calcification.;Secondary Objective: To compare the changes in markers of vascular calcification(crp, PTH, Fetuin-A, lipids, insulin, FGF-23, MSCT) and decreased kidney function (Cr-EDTA and albuminuria) ;Primary end point(s): This study is powered to evaluate wheter the treatment modalities 1. prevents loss of kidney function measured by Cr EDTA clearence 2. reduces proteinuria

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Countries

Denmark

Outcome results

None listed

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