Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA Mesangioproliferative Glomerulonephritis

Conditions
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IGA Glomerulonephritis

Intervention / Treatment
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* Drug: Ramipril or losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: anti-angiotensin II drugs<br>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. | Drug: Ramipril or losartan<br>* Ramipril (5 mg/day) was started soon after the enrollment and continued throughout the follow-up, having Losartan (50 mg/day) as alternative.<br>* Other names: renin-angiotensin system (RAS) inhibitors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function and proteinuria | 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. | at the end of first year of observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum levels of creatinine |  | at the end of first years of observation |