The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.
Considering the inhibitor activity of Everolimus on mTOR, our hypothesis is to evaluate its possible utility on the progression of CKD in ADPKD patients by reducing the rate of increase of renal cysts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
0.75 mg x 2 / day
A.O. Spedali Civili Di Brescia
Brescia, Italy
Alessandro Manzoni Hospital, Nephrology and Dialysis Department
Lecco, Italy
Modena Hospital
Modena, Italy
Dipartimento di Patologia Sistematica - Università Federico 2°
Naples, Italy
Reduction of GFR (according to MDRD formula) during a two-year follow up
Time frame: Two year-followup
reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up
Time frame: Two year-followup
changes in kidney size and renal and liver cysts dimensions evaluated by NMR at basal and at the end of the study
Time frame: Two year-followup
safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events
Time frame: Two year-followup
evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point
Time frame: Two year-followup
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department
Piacenza, Italy
C.M.I.D. - Presidi Ospedalieri ASL 4
Torino, Italy
Ospedale Civile San Bortolo Vicenza
Vicenza, Italy