Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

University Magna Graecia

Status and phase: Completed; Phase 4

Conditions: IGA Glomerulonephritis

Treatments: Drug: Ramipril or losartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01115426

IGAMsPGNPMsPGN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

anti-angiotensin II drugs

Other group

Description:

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.

Treatment:

Drug: Ramipril or losartan