A prospective, randomized, 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005951-14-IT

Enrollment

120

Registered

2007-03-29

Start date

2007-01-25

Completion date

Unknown

Last updated

2021-07-12

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

Conditions

Diabetic nephropathy MedDRA version: 6.1 Level: PT Classification code 10061835

Interventions

Trade Name: CIBACEN Pharmaceutical Form: Tablet INN or Proposed INN: Benazepril Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: CIBACEN Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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 les than 3.5 mg/dl ; -Urinary albumin to creatinine ratio of 2000mg/g or more in spot morning urine ; -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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Specific contraindications or history of hypersensitivity to the study drugs or other; -Serum potassium 8805; 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 immunologically-mediated 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate whether, at comparable blood pressure control, dual RAS blockade with combined therapy with halved doses of benazepril 10 mg/day and valsartan 160 mg/day reduces the incidence of ESRD more effectively than single drug RAS blockade by full doses of benazepril 20 mg/day or valsartan 320 mg/day given alone in high-risk patients with type 2 diabetes and overt nephropathy.;Secondary Objective: - To evaluate whether, at comparable blood pressure control, the effects of benazepril and valsartan therapy are similar or whether, alternatively, one of the two treatments offers a superior protective effect against the progression to ESRD in the above study population. - To evaluate the effects of the three study treatments on the incidence of fatal and non-fatal cardiovascular events, doubling of baseline serum creatinine, GFR decline and proteinuria, - To assess the relationships, in the study group as a whole and within each treatment group, between renal outcome variables ESRD, doubling serum creatinine, GFR decline, proteinuria and fatal and non-fatal cardiovascular events, between achieved blood pressure or metabolic control and renal and/or cardiovascular outcome variables and between achieved proteinuria reduction or residual follow-up proteinuria and renal and/or cardiovascular outcome variables.;Primary end point(s): Progression to ESRD i.e. need for renal replacement therapy by chronic dialysis or renal transplantation	—

Measure

Time frame

Main Objective: To evaluate whether, at comparable blood pressure control, dual RAS blockade with combined therapy with halved doses of benazepril 10 mg/day and valsartan 160 mg/day reduces the incidence of ESRD more effectively than single drug RAS blockade by full doses of benazepril 20 mg/day or valsartan 320 mg/day given alone in high-risk patients with type 2 diabetes and overt nephropathy.;Secondary Objective: - To evaluate whether, at comparable blood pressure control, the effects of benazepril and valsartan therapy are similar or whether, alternatively, one of the two treatments offers a superior protective effect against the progression to ESRD in the above study population. - To evaluate the effects of the three study treatments on the incidence of fatal and non-fatal cardiovascular events, doubling of baseline serum creatinine, GFR decline and proteinuria, - To assess the relationships, in the study group as a whole and within each treatment group, between renal outcome variables ESRD, doubling serum creatinine, GFR decline, proteinuria and fatal and non-fatal cardiovascular events, between achieved blood pressure or metabolic control and renal and/or cardiovascular outcome variables and between achieved proteinuria reduction or residual follow-up proteinuria and renal and/or cardiovascular outcome variables.;Primary end point(s): Progression to ESRD i.e. need for renal replacement therapy by chronic dialysis or renal transplantation

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Countries

Italy, Slovenia

Outcome results

None listed

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