Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

IGA Glomerulonephritis Clinical Trial

Official title:

Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA Mesangioproliferative Glomerulonephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115426
• Other study ID #: IGAMsPGNPMsPGN
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2010
• Last updated: April 30, 2010
• Start date: January 1997
• Est. completion date: January 2008

Study information

• Verified date: January 1997
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2008
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glomerulonephritis
• Glomerulonephritis, IGA
• IGA Glomerulonephritis

Intervention

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.

Locations

Country	Name	City	State
Italy	"Mater Domini" Hospital	Catanzaro	Calabria

Sponsors (1)

Lead Sponsor	Collaborator
University Magna Graecia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function and proteinuria	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.	at the end of first year of observation	No
Secondary	serum levels of creatinine		at the end of first years of observation	No