Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

This study has been completed.
Information provided by:
University Magna Graecia Identifier:
First received: April 28, 2010
Last updated: April 30, 2010
Last verified: January 1997

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.

Condition Intervention Phase
IGA Glomerulonephritis
Drug: Ramipril or losartan
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University Magna Graecia:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • serum levels of creatinine [ Time Frame: at the end of first years of observation ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 1997
Study Completion Date: January 2008
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01115426

"Mater Domini" Hospital
Catanzaro, Calabria, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Study Chair: Giorgio Fuiano, Professor "Magna Graecia" University of Catanzaro, Nephrology Unit
  More Information

No publications provided by University Magna Graecia

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pierangela Presta, "Magna Graecia" University of Catanzaro, Nephrology Unit Identifier: NCT01115426     History of Changes
Other Study ID Numbers: IGAMsPGNPMsPGN
Study First Received: April 28, 2010
Last Updated: April 30, 2010
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin II
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on April 16, 2014