Diabetes Clinical Trial
— VALIDOfficial title:
A Prospective, Randomized, Probe Trial to Evaluate Whether,at Comparable Blood Pressure Control,Combined Therapy With ACEI BEN and ARB VAL Reduces Progression to ESRD More Effectively Than BEN or VAL Alone in High Risk Patients With Type 2 Diabetes and Overt Nephropathy
Verified date | May 2016 |
Source | Mario Negri Institute for Pharmacological Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
Nephropathy of type 2 diabetes is the leading cause of end stage renal disease (ESRD)
world-wide and is associated with a dramatic excess cardiovascular morbidity and mortality.
Two randomized trials found that angiotensin II receptor blockers (ARBs) reduce the
incidence of ESRD by about 30%, but have no appreciable effects on cardiovascular mortality.
Available data suggest that ACE inhibitors might be similarly renoprotective and even more
cardioprotective, but large scale trials on ACE inhibitors, alone or combined with ARBs, in
overt nephropathy of type 2 diabetes are missing.
This study will compare the effects, at comparable blood pressure control
(systolic/diastolic <130/80 mmHg), of dual renin-angiotensin-system (RAS) blockade by half
dose of benazepril and valsartan combination therapy as compared to single RAS blockade by
benazepril or valsartan alone at full dose, 20 mg and 160 mg respectively, on ESRD and
cardiovascular events in high-risk patients with type 2 diabetes and overt nephropathy,
defined as serum creatinine >1.8 mg/dl and < 3.2 mg/dl and spot morning urine albumin to
creatinine ratio >1000mg/g for the patients without previous ACE inhibitor and ARB therapy
and >500mg/g for the patients with previous ACE inhibitor or ARB therapy and no specific
contraindications to the study drugs. The relationships between renal and cardiovascular
outcomes will also be evaluated.
102 patients will be treated for at least 3 years. At comparable blood pressure control, the
study is expected to show a more effective reduction in ESRD and cardiovascular events with
combined than with single drug ACE inhibitor or ARB therapy. As compared to ARB, ACE
inhibitor therapy is expected to have a similar effect on ESRD, but a superior
cardioprotective effect. Applied to clinical practice, the findings should help reducing
renal and cardiovascular complications, and related treatment costs, of type 2 diabetes.
Status | Completed |
Enrollment | 102 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
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 less than 3.5 mg/dl); - Urinary albumin to creatinine ratio >1000mg/g for the patients without previous ACE inhibitor and ARB therapy and >500mg/g for the patients with previous ACE inhibitor or ARB therapy (in spot morning urine) - Legal capacity; - Written informed consent. Exclusion Criteria: - 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 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; - Dual RAS blockade with an ACE inhibitor and an ARB. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Hospital "S.Marta e S.Venera" | Acireale | Catania |
Italy | Hospital "Azienda Ospedaliera Ospedali Riuniti di Bergamo" - Unit of Diabetology | Bergamo | |
Italy | Hospital "Vittorio Emanuele-Ferrarotto-Santo Bambino" | Catania | |
Italy | IRCCS San Raffaele - Unit of General Medicine | Milan | |
Italy | University "Federico II" | Napoli | |
Italy | Hospital "Azienda Ospedaliera di Parma" - Unit of Nephrology | Parma | |
Italy | Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" - Ambulatory of Ponte San Pietro | Ponte San Pietro | |
Italy | Clinical Research Center for Rare Diseases "Aldo e Cele Daccò" | Ranica | Bergamo |
Italy | Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Unit of Diabetology and Metabolic Diseases | Romano di Lombardia | |
Italy | Hospital " Casa Sollievo della Sofferenza" - Unit of Nephrology | San Giovanni Rotondo | Foggia |
Italy | University - AUSL 1 - Institute of Medical Pathology | Sassari | |
Italy | Hospital "Bolognini" | Seriate | Bergamo |
Italy | Hospital "G:Mazzini" | Teramo | |
Italy | Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases | Treviglio | |
Slovenia | Clinical Department of Endocrinology, Diabetes and Metabolic Diseases University Medical Centre Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
Mario Negri Institute for Pharmacological Research | Agenzia Italiana del Farmaco |
Italy, Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression to ESRD (i.e. need for renal replacement therapy by chronic dialysis or renal transplantation) | 4 times a year | Yes | |
Secondary | Doubling of serum creatinine (versus baseline), Rate of GFR decline, Incidence of fatal and non-fatal cardiovascular events (stroke, acute myocardial infarction, sudden death), Albumin to creatinine ratio and 24-hour urinary protein excretion. | 4 times a year | Yes |
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