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Trial: NCT01009957 [RDF]

Label NCT01009957
Slug nct01009957
Trialid NCT01009957
Lookup name NCT01009957
Lastchanged date June 10, 2010
Firstreceived results date
Firstreceived date November 6, 2009
Id info nct id NCT01009957
Overall status Recruiting
Id info secondary id
Biospec retention
Required header link text Link to the current record.
Enrollment 90
Number of arms 2
Is section 801
Is fda regulated No
Brief title Everolimus on CKD Progression in ADPKD Patients
Official title Everolimus on CKD Progression in ADPKD Patients
Study type Interventional
Id info nct alias
Completion date December 2012
Verification date June 2010
Why stopped
Id info org study id PolEver
Required header url
Study design Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Source A. Manzoni Hospital
Primary completion date December 2012
Brief summary
Number of groups
Required header download date Information obtained from on June 01, 2011
Phase Phase 2/Phase 3
Start date June 2008
Has expanded access No
Biospec descr
Detailed description 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.
Condition browse 1f7b5799f63086ab2db988d286a8c371
Intervention browse 1507e9fa1b9993f1d8234214a8ceebcd
Responsible party daf3b58bc948384aec78f7bfa3f01cdf
Overall contact Simeone Andrulli, MD (Contact)
Overall contact backup None
Sponsor group 6e66bc54764e5149a14cf65168cdb74b
Oversight info Italy: Ethics Committee (Oversight_info)
Eligibility 539b86727953902f2d59a52791567f46
Keywords ADPKD, CKD, Everolimus, Renal disease progression
Conditions Polycystic Kidney Diseases
Locations 15ec638eb43dc4a43673f0e1af457fd7, 2162ae94b3146f671f1df4e9547d861f, 79ef6503dcf49563a50f012d9f60df65, e607c3aaac5dae8ecfef7bd80b17ac8d, ebbe98ce78298a50ea37d91e703516ab
Links None
Results references None
Arm groups Everolimus (Arm Group), Standard therapy for CKD (Arm Group)
Location countries Italy
Interventions None
Secondary outcomes 73c8cec030e4883521da1cab6e307480, d46ff46dbfcd7831343f975e293bca51, e093e9200a52a99a07ce120a135149d5, fa73364918ee29a50147315196496785
References None
Primary outcomes 5cc2045d9a4bc6a9f18d2397f56a0f82
Removed countries None
Overall officials 2208a253116d5be99664d0bad6fa4b5a