Effects of an Intensified Treatment With ACE-I,ATA II and Statins in Alport Syndrome
Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Mario Negri Institute for Pharmacological Research