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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

April 28, 2010
April 30, 2010
January 1997
January 2007   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01115426 on ClinicalTrials.gov Archive Site
serum levels of creatinine [ Time Frame: at the end of first years of observation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA 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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
IGA Glomerulonephritis
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
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.
Intervention: Drug: Ramipril or losartan
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2008
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01115426
IGAMsPGNPMsPGN
Yes
Pierangela Presta, "Magna Graecia" University of Catanzaro, Nephrology Unit
University Magna Graecia
Not Provided
Study Chair: Giorgio Fuiano, Professor "Magna Graecia" University of Catanzaro, Nephrology Unit
University Magna Graecia
January 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP