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Clinical Trial Details

Trial ID: L0304
Source ID: NCT01009957
Associated Drug: Everolimus
Title: Everolimus on CKD Progression in ADPKD Patients
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Polycystic Kidney Diseases
Interventions: DRUG: Everolimus
Outcome Measures: Primary: Reduction of GFR (according to MDRD formula) during a two-year follow up, Two year-followup | Secondary: reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up, 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, Two year-followup|safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events, Two year-followup|evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point, Two year-followup
Sponsor/Collaborators: Sponsor: A. Manzoni Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 71
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-06
Completion Date: 2015-06
Results First Posted:
Last Update Posted: 2015-06-23
Locations: A.O. Spedali Civili Di Brescia, Brescia, Italy|Alessandro Manzoni Hospital, Nephrology and Dialysis Department, Lecco, 23900, Italy|Modena Hospital, Modena, 41100, Italy|Dipartimento di Patologia Sistematica - Università Federico 2°, Napoli, 80138, Italy|Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department, Piacenza, 29100, Italy|C.M.I.D. - Presidi Ospedalieri ASL 4, Torino, 10152, Italy|Ospedale Civile San Bortolo Vicenza, Vicenza, Italy
URL: https://clinicaltrials.gov/show/NCT01009957