Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

Phase 4

Completed

• Conditions: IGA Glomerulonephritis
• Interventions: Drug: Ramipril or losartan

• Registration Number: NCT01115426
• Lead Sponsor: University Magna Graecia

Brief Summary

This study evaluates prospectively the effects of an anti-angiotensin II regimen on renal outcome in patients with mesangioproliferative glomerulonephritis followed-up for 10 years.

Detailed Description

After signing informed consent, enrolled patients started treatment with ACEi. We decided to prescribe to all patients the same drug (ramipril) at the same dosage (5 mg/day). All patients were examined every 2 months during the first year of follow-up and every 6 months thereafter. At each visit, they underwent a complete physical examination. If the target blood pressure of \<140/90 mmHg was not achieved with ramipril monotherapy, addition of other antihypertensive drug(s) was allowed. Patients complaining adverse side effects attributed to ramipril were switched to losartan (50 mg/day). The patients were also prescribed a normal protein (1 gram/kg/day) and moderately salt-restricted (6-8 grams/day) diet throughout the study.

Study Timeline

• Status Verified: 1997-01
• Study Start: 1997-01
• Primary Completion: 2007-01
• Study Completion: 2008-01
• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-30
• Last Update Submitted: 2010-04-30
• Study First Posted: 2010-05-04
• Last Update Posted: 2010-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• proteinuria ≥ 1 g and < 3 g/24 hours stable during the 3 months of run-in
• microscopic hematuria (with at least 10 red blood cells per high-power field), without other signs or symptoms of systemic diseases stable during the 3 months of run-in
• no-evidence of renal failure or other relevant diseases
• biopsy diagnosis of I-II stage IgA- or pauciimmune-MsPGN

Exclusion Criteria

• estimated Glomerular Filtration Rate (eGFR) <80 ml/min/1.73m2
• previous immunosuppressive treatment
• blood pressure (BP) >150/90 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-angiotensin II drugs	Ramipril or losartan	Never treated patients with non-nephrotic proteinuria (1-3 g/day), microhematuria, no-evidence of renal failure or other relevant diseases and with diagnosis of I-II stage IgA- or pauciimmune-MsPGN were considered eligible.

Primary Outcome Measures

Name	Time	Method
renal function and proteinuria	at the end of first year of observation	In particular, the end points of the study were a loss \>20% of basal GFR and a decrease of basal daily proteinuria \< 20% at the end of first year of observation.; GFR was calculated using both the abbreviated Modification of Diet in Renal Disease (MDRD) study equation and measured creatinine clearance. For each patient, a time-averaged (TA) proteinuria were calculated as an average of the mean of every-6month period's 24-hour proteinuria measurements.

Secondary Outcome Measures

Name	Time	Method
serum levels of creatinine	at the end of first years of observation

Trial Locations

Locations (1)

"Mater Domini" Hospital; 🇮🇹 Catanzaro, Calabria, Italy