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Everolimus on CKD Progression in ADPKD Patients

This study is currently recruiting participants.
Verified April 2012 by A. Manzoni Hospital
Sponsor:
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT01009957
First received: November 6, 2009
Last updated: April 19, 2012
Last verified: April 2012
History of Changes

November 6, 2009
April 19, 2012
June 2008
December 2013   (final data collection date for primary outcome measure)
Reduction of GFR (according to MDRD formula) during a two-year follow up [ Time Frame: Two year-followup ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01009957 on ClinicalTrials.gov Archive Site
  • reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up [ Time Frame: Two year-followup ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events [ Time Frame: Two year-followup ] [ Designated as safety issue: Yes ]
  • evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point [ Time Frame: Two year-followup ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Everolimus on CKD Progression in ADPKD Patients
Everolimus on CKD Progression in ADPKD Patients

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Kidney Diseases
  • Drug: Everolimus
    0.75 mg x 2 / day
    Other Name: mTOR inhibitors
  • Drug: Standard Therapy
    Standard therapy for CKD
    Other Name: Conventional therapy for CKD
  • Experimental: Everolimus
    Everolimus + standard therapy for CKD
    Intervention: Drug: Everolimus
  • No Intervention: Standard therapy for CKD
    Standard therapy for CKD
    Intervention: Drug: Standard Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects over 18 years of both genders
  2. Clinical diagnosis of autosomal dominant polycystic kidney disease (ADPKD)
  3. GFR, according to MDRD formula, between 30 and 90 ml/min/1.73 mq
  4. Previous follow up of two years, with a creatinine evaluation at least once a year
  5. GFR reduction of at least 2.5 ml/min/year (according to MDRD formula)

Exclusion Criteria:

  1. Pregnancy, lactating, males and females without adequate contraception
  2. Leucopenia (< 3,000 leucocytes/mm3) or thrombocytopenia (< 100,000 platelets/mm3)
  3. Dyslipidemia (cholesterol or triglycerides > 260 mg/dl with treatment)
  4. Urinary tract infection
  5. Patients who cannot undergoing NMR
Both
18 Years and older
No
Contact: Simeone Andrulli, MD +390341489847 s.andrulli@ospedale.lecco.it
Italy
 
NCT01009957
PolEver
Yes
Prof. Francesco Locatelli, A. Manzoni Hospital
A. Manzoni Hospital
Not Provided
Study Chair: Francesco Locatelli, MD Nephrology and Dialysis Department - A. Manzoni Hospital
A. Manzoni Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP