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Completed

NCT Number: NCT01115426

Inhibitors of Angiotensin II in Proteinuric 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

"Mater Domini" Hospital

Catanzaro, Calabria, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ramipril or losartan

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. serum levels of creatinine

    Time frame: at the end of first years of observation

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2007
Study completion
2008
First posted
May 4, 2010
Registry last updated
May 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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