Nephropathy In Type 2 Diabetes and Cardio-renal Events

PHASE4CompletedINTERVENTIONAL
Enrollment

850

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

December 31, 2011

Study Completion Date

May 31, 2019

Conditions
Diabetic Nephropathy
Interventions
DRUG

SoC therapy

the patients have to be treated according the standard good medical practice by any center

DRUG

irbesartan

"Therapy for hypertension:~\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die"

DRUG

ramipril

"Therapy for hypertension:~\- Step 1: irbesartan 300 mg/die and ramipril 10 mg/die"

DRUG

hydrochlorothiazide

"Therapy for hypertension~\- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine \<2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)"

DRUG

furosemide

"Therapy for hypertension~\- Step 2: Diuretic (hydrochlorothiazide 12.5-25 mg/die if serum creatinine \<2 mg/dl, furosemide 25-75 mg/die if serum creatinin ≥2 mg/dl)"

DRUG

amlodipine

"Therapy for hypertension~\- Step 3: amlodipine up to 10 mg/die"

DRUG

atenolol

"Therapy for hypertension~\- Step 4: atenolol up to 100 mg/die"

DRUG

doxazosin

"Therapy for hypertension~\- Step 5: doxazosin up to 4 mg/die"

DRUG

clonidine

"Therapy for hypertension~\- Step 6: clonidine"

DRUG

insulin

"Therapy for Hyperglycaemia (to achieve HbA1c \<7):~\- insulin"

DRUG

simvastatin

"Therapy for hypercholesterolemia:~\- for reducing LDL cholesterol \< 100 mg/dl: simvastatin up to 80 mg/die"

DRUG

fibrate

"Therapy for hypertriglyceridemia~\- for reducing triglycerides \< 150 mg/dl and/or increasing HDL cholesterol \> 40-50 mg/dl: a fibrate"

DRUG

erythropoietin

"Treatment of anaemia:~\- erythropoietin"

DRUG

aspirin

"Antiplatelet therapy (in all patients without contraindications):~\- aspirin up to 160 mg/die"

Trial Locations (1)

I-80131

"Department of Advanced Medical and Surgical Sciences, Università della Campania Luigi Vanvitelli, Naples, Italy", Naples

All Listed Sponsors
lead

University of Campania Luigi Vanvitelli

OTHER

NCT00535925 - Nephropathy In Type 2 Diabetes and Cardio-renal Events | Biotech Hunter | Biotech Hunter