Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA Mesangioproliferative Glomerulonephritis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- renal function and proteinuria
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
anti-angiotensin II drugs
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.
Intervention: Ramipril or losartan (Drug)
Outcomes
Primary Outcomes
renal function and proteinuria
Time Frame: 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 Outcomes
- serum levels of creatinine(at the end of first years of observation)