Clinical Trial: Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA Mesangioproliferative Glomerulonephritis
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 Summary: 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.
Sponsor: University Magna Graecia
Current Primary Outcome: 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.
Original Primary Outcome: Same as current
Current Secondary Outcome: serum levels of creatinine [ Time Frame: at the end of first years of observation ]
Original Secondary Outcome: Same as current
Information By: University Magna Graecia
Dates:
Date Received: April 28, 2010
Date Started: January 1997
Date Completion:
Last Updated: April 30, 2010
Last Verified: January 1997
