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Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis

This study has been completed.
Sponsor:
Information provided by:
University Magna Graecia
ClinicalTrials.gov Identifier:
NCT01115426
First received: April 28, 2010
Last updated: April 30, 2010
Last verified: January 1997
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01115426

Locations
Italy
"Mater Domini" Hospital
Catanzaro, Calabria, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pierangela Presta, "Magna Graecia" University of Catanzaro, Nephrology Unit
ClinicalTrials.gov 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
Glomerulonephritis, IGA
Nephritis
Kidney Diseases
Urologic Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin II
Ramipril
Losartan
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

ClinicalTrials.gov processed this record on May 19, 2013