IGA Glomerulonephritis
Conditions
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.
Interventions
DRUGRamipril or losartan
Ramipril (5 mg/day) was started soon after the enrollment and continued throughout the follow-up, having Losartan (50 mg/day) as alternative.
Sponsors
University Magna Graecia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| serum levels of creatinine | at the end of first years of observation |
Countries
Italy
Outcome results
None listed