Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
Primary Purpose
IGA Glomerulonephritis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ramipril or losartan
Sponsored by
About this trial
This is an interventional treatment trial for IGA Glomerulonephritis
Eligibility 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
Sites / Locations
- "Mater Domini" Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
anti-angiotensin II drugs
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
serum levels of creatinine
Full Information
NCT ID
NCT01115426
First Posted
April 28, 2010
Last Updated
April 30, 2010
Sponsor
University Magna Graecia
1. Study Identification
Unique Protocol Identification Number
NCT01115426
Brief Title
Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
Official Title
Long-term Treatment by Inhibitors of Angiotensin II at Low Doses in Non-nephrotic Proteinuric Patients With Pauciimmune and IgA Mesangioproliferative Glomerulonephritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 1997
Overall Recruitment Status
Completed
Study Start Date
January 1997 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Magna Graecia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IGA Glomerulonephritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
anti-angiotensin II drugs
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ramipril or losartan
Other Intervention Name(s)
renin-angiotensin system (RAS) inhibitors
Intervention Description
Ramipril (5 mg/day) was started soon after the enrollment and continued throughout the follow-up, having Losartan (50 mg/day) as alternative.
Primary Outcome Measure Information:
Title
renal function and proteinuria
Description
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.
Time Frame
at the end of first year of observation
Secondary Outcome Measure Information:
Title
serum levels of creatinine
Time Frame
at the end of first years of observation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giorgio Fuiano, Professor
Organizational Affiliation
"Magna Graecia" University of Catanzaro, Nephrology Unit
Official's Role
Study Chair
Facility Information:
Facility Name
"Mater Domini" Hospital
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
22075320
Citation
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.
Results Reference
derived
Learn more about this trial
Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis
We'll reach out to this number within 24 hrs