The purpose of this study is to test in a pilot trial the efficacy and tolerance of sirolimus oral (at low doses) in patient to treat poor-prognosis IgA Nephropathy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
sirolimus starting at 1 mg/d (target 3-6 ng/ml) plus enalapril starting at 5 mg/d to control blood pressure plus atorvastatin starting at 10 mg/d
enalapril starting at 5 mg/d in order to control blood pressure. Atorvastatin starting at 10 mg/d
Nephrology Department. Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
To evaluate the effect of the administration of Rapamune on a clinical composite variable (change in proteinuria, blood pressure and hematuria) in patients with IgA nephropathy with poor prognosis criteria
Time frame: at month 12th
Change in the glomerular filtrate rate evaluated by means of radionuclide techniques (51Cr-EDTA) and comparison between both arms
Time frame: At months 6th and 12th
Change in renal histology
Time frame: At 12 months
Percentage of patients who withdraw from the study medication due to adverse events
Time frame: Within 1 year
Percentage of patients with therapeutic failure
Time frame: Within 1 year
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