Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
|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
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|