Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport Syndrome
|ClinicalTrials.gov Identifier: NCT00309257|
Recruitment Status : Completed
First Posted : March 31, 2006
Last Update Posted : October 6, 2009
Alport syndrome (AS) represents a form of progressive hereditary nephritis in which the genetic defect resides in the synthesis of one of several subunits of type IV collagen, the predominant constituent of basement membranes in renal glomeruli. Renal impairment occurs with time and severe renal failure with hypertension and uremia represent the end stage of the disease, even if a high variability in the rate of progression is described.Males are usually affected by a progressive form of the disease. Affected females with X-linked syndrome usually have a good prognosis with a mild renal impairment. The disease is also associated to a sensor neural deafness which can occur in approximately half of the patient affected and usually correlates with renal impairment. No definite treatment exists in order to delay the time of dialysis or a kidney transplant. Many studies showed that Angiotensin converting enzyme (ACE) inhibitors slow glomerular filtration rate (GFR) decline and limit progression to end stage renal disease (ERDS) and dialysis in several chronic nephropathies associated with proteinuria. The combination of ACE-I with Angiotensin II receptor antagonists may reduce proteinuria more effectively than the two drugs alone. Moreover the addition of statins may synergize the antiproteinuric effects of ACE-I and ATAII antagonists in experimental models of chronic renal diseases.
The purpose of this study is to evaluate the effect of a standardized multimodal nephroprotection intervention (Remission Clinic) in Alport patients with renal involvement.
|Condition or disease||Intervention/treatment||Phase|
|Alport Syndrome||Drug: ACE I, ATA II and Statins Drug: Benazepril, Valsartan and Fluvastatin||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of an Intensified Treatment With ACE-inhibitors, Angiotensin II Receptor Antagonists and Statins in Alport Syndrome|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||October 2009|
U.S. FDA Resources
|Experimental: ACE inhibitor, ATA II antagonists and Statins||
Drug: ACE I, ATA II and Statins
Drug: Benazepril, Valsartan and Fluvastatin
Patients will be given a low dose of Benazepril, 10 mg/die,that, if tolerated, will be up-titrated, after a week,to 20 mg/day.
Patients will be given Valsartan, 80 mg/die,up-titrated after a week to 160 mg/die. Fluvastatin will be started at 40 mg/die.If tolerated, will up-titrated to 80 mg/die. In case of liver, muscular or renal toxicity, fluvastatin will be back-titrated to 40 mg or withdrawn as deemed appropriate.
- Urinary protein excretion [ Time Frame: At baseline and monthly ]
- Blood pressure [ Time Frame: At baseline, monthly and when deemed clinically appropriate ]
- Urinary podocyte excretion [ Time Frame: At baseline and every six months. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00309257
|Clinical Research Center for Rare Diseases|
|Ranica, Bergamo, Italy, 24020|
|Principal Investigator:||Erica Daina, MD||Mario Negri Institute for Phrmacological Research|