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Everolimus on CKD Progression in ADPKD Patients

This study has been terminated.
(After primary completition date, experimental drug was no longer available)
Information provided by (Responsible Party):
Prof. Francesco Locatelli, A. Manzoni Hospital Identifier:
First received: November 6, 2009
Last updated: June 22, 2015
Last verified: June 2015
The study will evaluate whether the administration of everolimus (1.5 mg/day) can slow down the progression of CKD in ADPKD patients.

Condition Intervention Phase
Polycystic Kidney Diseases
Drug: Everolimus
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Everolimus on CKD (Chronic Kidney Disease) Progression in ADPKD Patients

Resource links provided by NLM:

Further study details as provided by A. Manzoni Hospital:

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

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

Enrollment: 71
Study Start Date: June 2008
Study Completion Date: June 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01009957

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
Study Chair: Francesco Locatelli, MD Nephrology and Dialysis Department - A. Manzoni Hospital
  More Information

Responsible Party: Prof. Francesco Locatelli, A. Manzoni Hospital Identifier: NCT01009957     History of Changes
Other Study ID Numbers: PolEver
Study First Received: November 6, 2009
Last Updated: June 22, 2015

Keywords provided by A. Manzoni Hospital:
Renal disease progression

Additional relevant MeSH terms:
Kidney Diseases
Disease Progression
Polycystic Kidney Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Kidney Diseases, Cystic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents processed this record on April 26, 2017