Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

NCT ID: NCT01115426

Last Updated: 2010-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-01-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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IGA Glomerulonephritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Ramipril or losartan

Intervention Type DRUG

Ramipril (5 mg/day) was started soon after the enrollment and continued throughout the follow-up, having Losartan (50 mg/day) as alternative.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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renin-angiotensin system (RAS) inhibitors

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Magna Graecia

OTHER

Sponsor Role lead

Responsible Party

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"Magna Graecia" University of Catanzaro, Nephrology Unit

Principal Investigators

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Giorgio Fuiano, Professor

Role: STUDY_CHAIR

"Magna Graecia" University of Catanzaro, Nephrology Unit

Locations

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"Mater Domini" Hospital

Catanzaro, Calabria, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 22075320 (View on PubMed)

Other Identifiers

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IGAMsPGNPMsPGN

Identifier Type: -

Identifier Source: org_study_id

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