NCT01115426

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 1997

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
Last Updated

May 4, 2010

Status Verified

January 1, 1997

Enrollment Period

10 years

First QC Date

April 28, 2010

Last Update Submit

April 30, 2010

Conditions

IGA Glomerulonephritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • serum levels of creatinine

    at the end of first years of observation

Study Arms (1)

anti-angiotensin II drugs

OTHER

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

Interventions

Ramipril or losartanDRUG

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

Also known as: renin-angiotensin system (RAS) inhibitors
anti-angiotensin II drugs

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • estimated Glomerular Filtration Rate (eGFR) \<80 ml/min/1.73m2
  • previous immunosuppressive treatment
  • blood pressure (BP) \>150/90 mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"Mater Domini" Hospital

Catanzaro, Calabria, 88100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22075320DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

RamiprilLosartanRenin-Angiotensin System

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingTetrazolesMetabolismHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Giorgio Fuiano, Professor

    "Magna Graecia" University of Catanzaro, Nephrology Unit

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 4, 2010

Study Start

January 1, 1997

Primary Completion

January 1, 2007

Study Completion

January 1, 2008

Last Updated

May 4, 2010

Record last verified: 1997-01

Locations

IT(1)