Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

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

• Status: Completed
• Conditions: IGA Glomerulonephritis
• Intervention / Treatment: Drug: Ramipril or losartan

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • "Mater Domini" Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: renin-angiotensin system (RAS) inhibitors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
serum levels of creatinine	at the end of first years of observation

Collaborators and Investigators

• Sponsor: University Magna Graecia
• Investigators: Study Chair: Giorgio Fuiano, Professor, "Magna Graecia" University of Catanzaro, Nephrology Unit

Publications and helpful links

General Publications

• Presta P, Minutolo R, Iodice C, Comi N, Casoria V, Fuiano L, Caglioti C, Conte G, Fuiano G. Renin-angiotensin system inhibitors reduce the progression of mesangioproliferative glomerulonephritis: 10 year follow-up. Eur J Intern Med. 2011 Dec;22(6):e90-4. doi: 10.1016/j.ejim.2011.08.021. Epub 2011 Sep 28.

Study record dates

Study Major Dates

• Study Start: January 1, 1997
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: April 28, 2010
• First Submitted That Met QC Criteria: April 30, 2010
• First Posted (Estimate): May 4, 2010

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: April 30, 2010
• Last Verified: January 1, 1997

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Glomerulonephritis, IGA; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Losartan; Ramipril
• Other Study ID Numbers: IGAMsPGNPMsPGN