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

Phase 1

Conditions: decreased renal function (CKD II-IV), creatinin clearance 15-90 ml/min
MedDRA version: 18.0Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 18.0Level: LLTClassification code 10013231Term: Disorder kidneySystem Organ Class: 10038359 - Renal and urinary disorders

Registration Number: EUCTR2008-004099-26-DK

Lead Sponsor: Departmnet of nephrology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Cr EDTA clearence 25-70 ml/min
proteinuria > 0,5 g/day
s-potassium < 6mmol/l
signed informed consent
life expectancy > 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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br><br>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 <br>1. prevents loss of kidney function measured by Cr EDTA clearence <br>2. reduces proteinuria<br>

Secondary Outcome Measures