The Laboratory of Biostatistics of the Department of Renal Medicine provides statistical support to the design, conduct and analysis of randomized clinical trials, mainly in the field of diabetic and non-diabetic chronic renal disease, renal transplantation, dialysis and rare diseases. It is also involved in systematic reviews promoted by international networks. Data collection of quality of life and socio-economic factors in participants enrolled in clinical trials are also collected.
Advanced statistical tools are used:
- to identify prognostic factors of subsequent clinical events
- to perform a joint analysis of repeated measures of biomarkers and survival data
- to achieve statistical matching of treated and control groups by means of the propensity score when randomization is unfeasible in observational studies.
Randomized, double-blind DIABASI trial
The study is aimed at assessing the effect of 6-month Acetyl-L Carnitine therapy on arterial blood pressure, lipid and metabolic profile, and kidney function in 228 hypertensive patients with type 2 diabetes.
Randomized, double-blind PROCEED trial
The study is aimed at evaluating the effects of paricalcitol and salt intake in type 2 diabetic patients with proteinuric chronic diseases.
Randomized, multicenter, blinded endpoint ANSWER trial
The study is aimed at assessing the renal and humoral effects of sevelamer carbonate in patients with chronic kidney disease and residual proteinuria despite best available treatment.
Randomized, multicenter, blinded endpoint VALID trial
The study evaluates whether, at comparable blood pressure control, combined therapy with the ACE inhibitor Benazepril and the angiotensin II receptor blocker (ARB) Valsartan reduces progression to ESRD more effectively than Benazepril or Valsartan alone in high risk patients with type 2 diabetes and overt nephropathy.
Randomized, double-blind ALADIN 2 trial
The study is aimed at evaluating the effects of long-acting somatostatin (Octreotide LAR) therapy on disease progression in patients with autosomal dominant polycystic kidney disease and moderate to severe renal insufficiency.
Randomized, multicenter, blinded endpoint ATHENA trial
The study is aimed at comparing the incidence of biopsy-proven Chronic Allograft Nephropathy three years post-transplant in kidney recipients randomly allocated to MMF or AZA, after induction therapy with basiliximab and low-dose RATG, and sequential steroid and CsA withdrawal.
Randomized, multicenter, blinded endpoint ARCADIA trial
The study is aimed at evaluating whether at comparable blood pressure control, ACE inhibitor therapy more effectively than non RAS inhibitor therapy reduce cardiovascular morbidity and mortality in patients with chronic dialysis of more than six months and with left ventricular hypertrophy and/or arterial hypertension.
Prospective, cohort, multicenter study on the role of anti-PLA2R1 epitope
The study is aimed at evaluating the predictive role of anti-PLA2R1 epitope spreading from the immunodominant CysR domain to CTLD1 and CTLD7 domains in 117 consecutive, rituximab-treated patients with PLA2R1-related MN and nephrotic syndrome.
International Consensus on Cardiopulmonary Resuscitation.