CompletedPhase 4ACTRN12610000034033

Intensive versus Conventional Therapy to Slow the Progression of Idiopathic Glomerular Diseases

Intensive versus Conventional Therapy on proteinuria and renal function in patients diagnosed with Glomerular Diseases


Sponsor

ASL6 Spedali Riuniti Livorno

Enrollment

130 participants

Start Date

Jan 1, 2003

Study Type

Interventional

Conditions

Summary

The main purpose of this study was to compare effects on proteinuria and renal function of two different therapeutic regimens: The first, was based on intensive therapy, which comprised a combination of renin angiotensin system inhibitors (Angiotensin converting enzyme inhibitors plus angiotensin receptor blocker spironolactone) and a dose of statin to achieve a low density lipoprotein ( LDL) cholesterol target less than 100 mg /dl. The second regimen (representative of a more conventional therapy) was based only on an angiotensin convertin enzyme inhibitors plus a dose of statin to achieve a low density lipoprotein ( LDL) cholesterol target less than 130 mg/dl


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 80 Yearss

Inclusion Criteria1

  • Patients with estimated GFR>30 mL/min/1.73 m2 (36-102 mL/min/1.73 m2), Patients included had a clinical diagnosis of idiopathic chronic glomerulonephritis with urine protein >1g/g creatinine, confirmed at least in two separate occasions.

Exclusion Criteria1

  • Patients with membranous glomerulonephritis and minimal change disease were excluded because of the possibility of spontaneous remission and the unpredictable response of these patients to treatment. Patients with diabetes mellitus, renovascular or malignant hypertension, secondary glomerular disease, rapidly progressive glomerulonephritis, malignancies, myocardial infarction, or cerebrovascular accident within the 6 months preceding the study, congestive heart failure, hepatic dysfunction, serum potassium >5 mEq/l, eGFR<30 ml/min/1.73m2, and a history of intolerance to angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers ( ARBs) . We excluded patients treated with steroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive agents within 6 months preceeding the study and patients previously treated with these drugs and achieving long period of remission.

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Interventions

We have studied two group of patients comparing intensive treatment versus standard treatment : In the intensive treatment group we used a combination of several drug including: Angiotensin convertin

We have studied two group of patients comparing intensive treatment versus standard treatment : In the intensive treatment group we used a combination of several drug including: Angiotensin converting enzyme inhibitor, (Ramipril;oral capsules dose- range 5-10 mg daily for 36 months prescribed by physician based on clinical variables) and Angiotensin receptor blocker (Irbesartan oral capsules: dose-range 150-300 mg daily for 36 months, prescribed by physician based on clinical variables ) to achieve a blood pressure goal of less than 130 /80 mm/Hg; Atorvastatin oral capsules (dose-range 20-40 mg daily for 36 months, prescribed by physician based on clinical variables ) to achieve low density lipoprotein ( LDL) cholesterol level less than 100 mg/dl; spironolactone, oral capsules (dose-range 25-50 mg daily, for 36 months,prescribed by physician based on clinical variables ) titrated to maintain serum potassium level less than 5.5 mEq/l. Patients in this group receive all 4 drugs on a daily basis.


Locations(1)

Livorno, Italy

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ACTRN12610000034033