Everolimus on CKD Progression in ADPKD Patients

June 22, 2015 updated by: Prof. Francesco Locatelli, A. Manzoni Hospital

Everolimus on CKD (Chronic Kidney Disease) 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy
        • A.O. Spedali Civili di Brescia
      • Lecco, Italy, 23900
        • Alessandro Manzoni Hospital, Nephrology and Dialysis Department
      • Modena, Italy, 41100
        • Modena Hospital
      • Napoli, Italy, 80138
        • Dipartimento di Patologia Sistematica - Università Federico 2°
      • Piacenza, Italy, 29100
        • Ospedale "Guglielmo da Saliceto" - Nephrology and Dialysis Department
      • Torino, Italy, 10152
        • C.M.I.D. - Presidi Ospedalieri ASL 4
      • Vicenza, Italy
        • Ospedale Civile San Bortolo Vicenza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Everolimus
Everolimus + standard therapy for CKD
Drug: Everolimus
0.75 mg x 2 / day
Other Names:
  • mTOR inhibitors
NO_INTERVENTION: Control
Standard therapy for CKD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of GFR (according to MDRD formula) during a two-year follow up
Time Frame: Two year-followup
Two year-followup

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A. Manzoni Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (ESTIMATE)

November 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PolEver

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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