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Trial registered on ANZCTR


Registration number
ACTRN12610000034033
Ethics application status
Approved
Date submitted
6/10/2009
Date registered
13/01/2010
Date last updated
13/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intensive versus Conventional Therapy to Slow the Progression of Idiopathic Glomerular Diseases
Scientific title
Intensive versus Conventional Therapy on proteinuria and renal function in patients diagnosed with Glomerular Diseases
Secondary ID [1] 1256 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
progression renal disease due to Idiopathic Glomerular Diseases 243880 0
Condition category
Condition code
Renal and Urogenital 252053 252053 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We have studied two group of patients comparing intensive treatment versus standard treatment : In the intensive treatment group we used a combination of several drug including: Angiotensin converting enzyme inhibitor, (Ramipril;oral capsules dose- range 5-10 mg daily for 36 months prescribed by physician based on clinical variables) and Angiotensin receptor blocker (Irbesartan oral capsules: dose-range 150-300 mg daily for 36 months, prescribed by physician based on clinical variables ) to achieve a blood pressure goal of less than 130 /80 mm/Hg; Atorvastatin oral capsules (dose-range 20-40 mg daily for 36 months, prescribed by physician based on clinical variables ) to achieve low density lipoprotein ( LDL) cholesterol level less than 100 mg/dl; spironolactone, oral capsules (dose-range 25-50 mg daily, for 36 months,prescribed by physician based on clinical variables ) titrated to maintain serum potassium level less than 5.5 mEq/l.
Patients in this group receive all 4 drugs on a daily basis.
Intervention code [1] 241312 0
Treatment: Drugs
Comparator / control treatment
In the control group we used the following combination: (Ramipril;oral capsules dose- range 5-10 mg daily for 36 months prescribed by physician based on clinical variables) to achieve blood pressure value goal of less than 130 /80 mm/Hg; Atorvastatin oral capsules (dose-range 10-40 mg daily for 36 months, prescribed by physician based on clinical variables ) to achieve low density lipoprotein ( LDL) cholesterol level less than 130 mg/dl.
Patients in this group receive all 2 drugs on a daily basis.
Control group
Active

Outcomes
Primary outcome [1] 252955 0
Effects on proteinuria ( urine albumin-to creatinine ratio)
Timepoint [1] 252955 0
3 years following randomisation
Secondary outcome [1] 257689 0
Effects on eGFR ( estimated glomerular filtration rate) Blood anlysis and calculated formula
Timepoint [1] 257689 0
3 years following randomisation

Eligibility
Key inclusion criteria
Patients with estimated GFR>30 mL/min/1.73 m2 (36-102 mL/min/1.73 m2), Patients included had a clinical diagnosis of idiopathic chronic glomerulonephritis with urine protein >1g/g creatinine, confirmed at least in two separate occasions.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with membranous glomerulonephritis and minimal change disease were excluded because of the possibility of spontaneous remission and the unpredictable response of these patients to treatment. Patients with diabetes mellitus, renovascular or malignant hypertension, secondary glomerular disease, rapidly progressive glomerulonephritis, malignancies, myocardial infarction, or cerebrovascular accident within the 6 months preceding the study, congestive heart failure, hepatic dysfunction, serum potassium >5 mEq/l, eGFR<30 ml/min/1.73m2, and a history of intolerance to angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers ( ARBs) . We excluded patients treated with steroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive agents within 6 months preceeding the study and patients previously treated with these drugs and achieving long period of remission.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 2148 0
Italy
State/province [1] 2148 0
Livorno

Funding & Sponsors
Funding source category [1] 243763 0
Self funded/Unfunded
Name [1] 243763 0
Address [1] 243763 0
Country [1] 243763 0
Funding source category [2] 243840 0
Hospital
Name [2] 243840 0
ASL6 Spedali Riuniti Livorno
Address [2] 243840 0
Viale Alfieri 36 Livorno 57100
Country [2] 243840 0
Italy
Primary sponsor type
Hospital
Name
ASL6 Spedali Riuniti Livorno
Address
Viale Alfieri 36 Livorno 57100
Country
Italy
Secondary sponsor category [1] 237190 0
None
Name [1] 237190 0
Address [1] 237190 0
Country [1] 237190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243893 0
Human Research Committee , Spedali Riuniti Livorno, Livorno, Italy
Ethics committee address [1] 243893 0
Direzione Sanitaria P.O. ASL6 Livorno 57100
Ethics committee country [1] 243893 0
Italy
Date submitted for ethics approval [1] 243893 0
Approval date [1] 243893 0
03/06/2002
Ethics approval number [1] 243893 0

Summary
Brief summary
The main purpose of this study was to compare effects on proteinuria and renal function of two different therapeutic regimens: The first, was based on intensive therapy, which comprised a combination of renin angiotensin system inhibitors (Angiotensin converting enzyme inhibitors plus angiotensin receptor blocker spironolactone) and a dose of statin to achieve a low density lipoprotein ( LDL) cholesterol target less than 100 mg /dl. The second regimen (representative of a more conventional therapy) was based only on an angiotensin convertin enzyme inhibitors plus a dose of statin to achieve a low density lipoprotein ( LDL) cholesterol target less than 130 mg/dl
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30307 0
Address 30307 0
Country 30307 0
Phone 30307 0
Fax 30307 0
Email 30307 0
Contact person for public queries
Name 13554 0
Bigazzi Roberto MD
Address 13554 0
U.O. di Nefrologia e Dialisi
Viale Alfieri 36 Livorno 57100
Country 13554 0
Italy
Phone 13554 0
0039586223360
Fax 13554 0
Email 13554 0
r.bigazzi@usl6.toscana.it
Contact person for scientific queries
Name 4482 0
Bigazzi Roberto MD
Address 4482 0
U.O. di Nefrologia e Dialisi
Viale Alfieri 36 Livorno 57100
Country 4482 0
Italy
Phone 4482 0
0039586223360
Fax 4482 0
Email 4482 0
r.bigazzi@usl6.toscana.it

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary