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Everolimus on CKD Progression in ADPKD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01009957
Recruitment Status : Terminated (After primary completition date, experimental drug was no longer available)
First Posted : November 9, 2009
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital

Brief Summary:
The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.

Condition or disease Intervention/treatment Phase
Polycystic Kidney Diseases Drug: Everolimus Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients
Study Start Date : June 2008
Actual Primary Completion Date : January 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Everolimus

Arm Intervention/treatment
Experimental: Everolimus
Everolimus + standard therapy for CKD
Drug: Everolimus
0.75 mg x 2 / day
Other Name: mTOR inhibitors

No Intervention: Control
Standard therapy for CKD

Primary Outcome Measures :
  1. Reduction of GFR (according to MDRD formula) during a two-year follow up [ Time Frame: Two year-followup ]

Secondary Outcome Measures :
  1. reduction of creatinine clearance and GFR (according to Cockcroft-Gault formula) during a two-year follow up [ Time Frame: Two year-followup ]
  2. 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 ]
  3. safety profile of everolimus (leucopenia, thrombocytopenia, lipid profile and other adverse events [ Time Frame: Two year-followup ]
  4. evaluation of phosphatemia, phosphaturia and urinary cytokines on primary end point [ Time Frame: Two year-followup ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009957

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A.O. Spedali Civili Di Brescia
Brescia, Italy
Alessandro Manzoni Hospital, Nephrology and Dialysis Department
Lecco, Italy, 23900
Modena Hospital
Modena, Italy, 41100
Dipartimento di Patologia Sistematica - Università Federico 2°
Napoli, Italy, 80138
Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department
Piacenza, Italy, 29100
C.M.I.D. - Presidi Ospedalieri ASL 4
Torino, Italy, 10152
Ospedale Civile San Bortolo Vicenza
Vicenza, Italy
Sponsors and Collaborators
A. Manzoni Hospital
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Study Chair: Francesco Locatelli, MD Nephrology and Dialysis Department - A. Manzoni Hospital
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Responsible Party: Prof. Francesco Locatelli, A. Manzoni Hospital Identifier: NCT01009957    
Other Study ID Numbers: PolEver
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Keywords provided by Prof. Francesco Locatelli, A. Manzoni Hospital:
Renal disease progression
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Disease Progression
Urologic Diseases
Disease Attributes
Pathologic Processes
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs