A prospective, randomised, open-label blinded end point (PROBE) trial to evaluate, whether, at comparable blood pressure control, combined therapy with the ACE inhibitor benazepril and the angiotensin II receptor blocker (ARB) valsartan reduces progression to ESRD more effectively than benazepril or valsartan alone in high risk patients with type 2 diabetes and overt nephropathy (VALID study) - VALID study
- Conditions
- overt nephropathy in type 2 diabetes
- Registration Number
- EUCTR2006-005951-14-SI
- Lead Sponsor
- Italian Drug Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 103
- Males and females >40 years old;
- High-risk subjects with type 2 diabetes (WHO criteria);
- Serum creatinine concentration of 1.8 mg/dl or more (but less than 3.5 mg/dl);
- Urinary albumin to creatinine ratio of 2000mg/g or more (in spot morning urine);
- Legal capacity;
- Written 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)
F.1.3.1 Number of subjects for this age range
- Specific contraindications or history of hypersensitivity to the study drugs or
other;
- Serum potassium = 6 mEq/L despite diuretic therapy, and optimized metabolic
and acid/base control;
- Bilateral renal artery stenosis;
- Previous history of allergy or intolerance, or evidence of immunologicallymediated
renal disease, systemic diseases, cancer;
- Drug or alcohol abuse;
- Any chronic clinical conditions that may affect completion of the trial or confound
data interpretation;
- Pregnancy or lactating;
- Women of childbearing potential without following a scientifically accepted form
of contraception;
- Legal incapacity and/or other circumstances rendering the patient unable to
understand the nature, scope and possible consequence of the trial;
- Evidence of an uncooperative attitude;
- Any evidence that patient will not be able to complete the trial follow-up.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The study will compare the effects, at comparable blood pressure control<br>(systolic/diastolic <130/80 mmHg), of dual renin-angiotensin-system (RAS) blockade<br>by benazepril (perindopril) and valsartan combination therapy as compared to single RAS<br>blockade by benazepril (perindopril) or valsartan alone on ESRD and cardiovascular events in high-risk patients with type 2 diabetes and overt nephropathy. ;Secondary Objective: The relationships<br>between renal and cardiovascular outcomes will also be evaluated.;Primary end point(s): Progression to ESRD (i.e. need for renal replacement therapy by chronic dialysis or<br>renal transplantation)<br>
- Secondary Outcome Measures
Name Time Method