Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA Mesangioproliferative Glomerulonephritis|
- renal function and proteinuria [ Time Frame: at the end of first year of observation ] [ Designated as safety issue: No ]
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.
- serum levels of creatinine [ Time Frame: at the end of first years of observation ] [ Designated as safety issue: No ]
|Study Start Date:||January 1997|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
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.
Drug: Ramipril 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.
Other Name: renin-angiotensin system (RAS) inhibitors
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01115426
|"Mater Domini" Hospital|
|Catanzaro, Calabria, Italy, 88100|
|Study Chair:||Giorgio Fuiano, Professor||"Magna Graecia" University of Catanzaro, Nephrology Unit|